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Medical device / Medical equipment / Medical technology / Premarket approval / Federal Food / Drug / and Cosmetic Act / Biocompatibility / Center for Devices and Radiological Health / Sterilization / Embolization / Medicine / Food and Drug Administration / Surgery


REVERSE MEDICAL TM ________K123803 510(k) SummaryJU Pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, Reverse Medical Corporation isproviding the summary of Substantial Equivalence for the
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Document Date: 2013-08-06 11:27:52

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City

Irvine / Plymouth / /

Company

K123803 Trade / MN MicroVention Inc. / Address Reverse Medical Corporation / CA InZone Detachment System Boston Scientific Inc / Target / Manufacturer 510(k) Number AGA Corporation / Guglielmi Detachable Coil Power Supply Boston Scientific Inc / Boston Scientific / Radiological Health Enclosure Reverse Medical Corporation / Reverse Medical Corporation / Linda D'Abate Reverse Medical / /

Event

FDA Phase / Reorganization / /

Facility

Drug Administralion New Hamphire Avenue Documnent Control Center / /

IndustryTerm

micro vascular occlusion device / internal communicating device / announcements concerning your device / predicate devices / manufacturing practice requirements / marketed predicate devices / manufacturing practice / intended treatment site / /

MarketIndex

Set 275 / /

MedicalCondition

vascular malformations / intracranial aneurysms / /

MedicalTreatment

catheter / embolization / /

Organization

Public Heajlh Service Food and Drug Administralion New Hamphire Avenue Documnent Control Center / Division of Postmarket Surveillance / office of Device Evaluation / office of Surveillance / FDA / Division of Small Manufacturers / International and Consumer Assistance / Cardiovasciilar Devices Office / /

Person

Brain D. Zuckerman / Jeffrey Valko / /

/

Position

Vice President / RA/CA/QA Date / General / Director Division / M.D. Director Division / /

Product

Result Summary Results/Acceptance Test Cytotoxicity Kligman Maximization Sensitization Test Intracutaneous Injection Systemic Injection / Federal Food / /

ProvinceOrState

Maryland / California / /

Technology

Design Verification / radiation / http / /

URL

www.fda.Eov/MedicalDevices/ResourcesforYou/Industry/default.html / www.fda.gov/MedicaiDevices/ResourcesforYou/Industry/default.htm / www.fda.povfMedicalDevices/Safetv/ReportaProblem/default.htm / /

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