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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameSILK SUTURES
Classification Namesuture, nonabsorbable, silk
Generic Namesuture, nonabsorbable, silk
Regulation Number878.5030
ApplicantLUKENS CORP.
PMA NumberN80989
Supplement NumberS001
Date Received03/06/1987
Decision Date04/24/1987
Product Code
GAP[ Registered Establishments with GAP ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
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