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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Device CryoSeal FS System
Classification Nameapparatus, autotransfusion
Generic Namefibrin sealant preparation device
Regulation Number868.5830
Applicant
ThermoGenesis Corp
2711 citrus road
Rancho Cordova , CA 95742 
  
PMA NumberBP060001
Date Received12/30/2005
Decision Date07/26/2007
Decision Approved
Product Code
CAC[ Registered Establishments with CAC ]
Advisory Committee Cardiovascular
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
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