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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.
 
DeviceSILK NONABSORBABLE SUTURES, USP
Generic NameSuture, nonabsorbable, silk
Regulation Number878.5030
ApplicantDavis & Geck, Inc.
American Cynamid Company
One Casper St.
Danbury, CT 06810
PMA NumberN84047
Supplement NumberS011
Date Received07/01/1986
Decision Date09/30/1986
Product Code GAP 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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