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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCOLLACOTE(R),COLLATAPE(R),COLLAPLUG(R), DRESSINGS
Classification Namematerial, dressing, surgical, polylactic acid
Generic Namematerial, dressing, surgical, polylactic acid
Applicant
COLLA-TEC, INC.
p.o. box 688
plainsboro, NJ 08536
PMA NumberP840062
Supplement NumberS006
Date Received07/25/1995
Decision Date09/08/1995
Product Code
LPG[ Registered Establishments with LPG ]
Advisory Committee Dental
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR AN ALTERNATE STERILIZATION FACILITY FOR COLLACOTE, COLLATAPE AND COLLAPLUG DRESSINGS AT FRIFFITH MICROSCIENCE, INC., 27 PARK ROAD, GLEN FALLS, NY 12801
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