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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.
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameagent, absorbable hemostatic, collagen based
Regulation Number878.4490
Datascope Corp.
14 philips pkwy.
montvale, NJ 07645
PMA NumberP850023
Date Received04/17/1985
Decision Date05/27/1986
Product Code
LMF[ Registered Establishments with LMF ]
Docket Number 86M-0248
Notice Date 07/07/1986
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 S008 S009 S010 
S011 S013 S014