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JUL WarrnAir 135 Device Modification Special 510(k) Special 510(k) Summary 1. COMPANY INFORMATION Cincinnati Sub-Zero Products, Inc.
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Document Date: 2012-08-06 18:52:34


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City

Cincinnati / /

Company

Cincinnati Sub-Zero Products Inc. / COMPANY INFORMATION Cincinnati Sub-Zero Products Inc. / /

Event

FDA Phase / /

/

IndustryTerm

fturther announcements concerning your device / patient temperature mhanagement device / predicate devices / trained healthcare professionals / manufacturing practice requirements / manufacturing methods / thermal energy / marketed predicate devices / manufacturing practice / Internet address http /

MedicalCondition

hypothermia / /

MusicGroup

Intensive Care / /

Organization

Division of Postmarket Surveillance / Food and Drug Administration V / #slon Sign-01T Division of Cardiovascular Devices / Center for Devices and Radiological Health / office of Compliance / Device Evaluation Center for Devices and Radiological Health Enclosure Indications for Use / FDA / Cardiovascular Devices Office / Intensive Care Unit / Surgical Intensive Care Unit / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / CDRLH's office of Surveillance / Post-anesthesia Care Unit / /

Person

Steven J. Berke / /

/

Position

President and CEO / President and Chief Executive Officer / Director Division / controller / /

Product

Federal Food / /

ProvinceOrState

Ohio / Maryland / /

Technology

radiation / heat transfer / ADO / /

URL

http /

SocialTag