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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.
 
Trade NameCOLLASTAT
Classification Nameagent, absorbable hemostatic, collagen based
Generic Namehemostatic agent
Regulation Number878.4490
ApplicantVITAPHORE CORP.
PMA NumberP810006
Date Received03/02/1981
Decision Date12/10/1981
Product Code
LMF[ Registered Establishments with LMF ]
Docket Number 81M-0402
Notice Date 01/05/1982
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S005 S006 S007 
S008 S009 S011 S012 S013 S016 
S017 S018 S019 S020 S021 S022 
S023 S024 S025 S026 S027 S028 
S029 S030 S031 S032 S033 S034 
S035 
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