otimidDi pAKIiiuxistaitionI Cincinnati Sub-Zero Products Inc. / 2GWf Cincinnati Sub-Zero Products Inc. / Cincinnati Sub-Zero Products Inc. / COMPANY INFORMATION Cincinnati Sub-Zero Products Inc. / /
Event
FDA Phase / /
Facility
The USB port / / /
IndustryTerm
announcements concerning your device / predicate device / manufacturing practice requirements / 222S device / marketed predicate devices / manufacturing practice / /
Organization
Division of Postmarket Surveillance / HUMAN SERVICES Public Health Service / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / Device Evaluation Center for Devices and Radiological Health Enclosure Indications for Use / FDA / Cardiovascular Devices Office / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Division of Cardiovascular DevicesPae1o1 / CDRH's office of Surveillance / /
Person
Steven J. Berke / D. Zuckerman / / /
Position
President / President and CEO / General / Director Division / /
FEB -4 2GWf Cincinnati Sub-Zero Products, Inc. Special 5 10(k) Premarket Notification for Device Modification Blanketrol 11 Model 222S K