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Laparoscopic surgery / Single port laparoscopy / Medical equipment / Invasiveness of surgical procedures / Medical device / SILS gastric banding / Cholecystectomy / Medicine / Endoscopy / Surgery


-3.510(K) SUMMARY KI\[removed]SUBMIrTER/51O(K) HOLDER Advanced Surgical Concepts
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Document Date: 2012-10-09 13:29:16


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City

QuadPort / /

Company

K121309 Trade / Hogan Lovells US LLP / Upper Dargie Road Bray Co. / /

Country

United States / Columbia / /

Event

FDA Phase / /

Facility

Columbia Square / /

IndustryTerm

announcements concerning your device / predicate device / manufacturing practice requirements / Internet address http /

OperatingSystem

L3 / /

Organization

Division of Postmarket Surveillance / Food and Drug Administration / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / FDA / Surgical Concepts Unit / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Surgical / Orthopedic and Restorative Devices Office / Device Evaluation Center for Devices and Radiological Health Enclosure / Mark N. Melkerson Director Division of Surgical / CDRH's office of Surveillance / /

Person

Hogan Lovells / Silver Spring / Jonathan Kahan / Mark N. Melkerson / Tripori / /

/

Position

CONSULTANT / /

Product

Federal Food / /

ProvinceOrState

District of Columbia / Maryland / /

Technology

Design Verification / radiation / fundamental scientific technology / /

URL

http /

SocialTag