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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameDEKLENE(TM)
Classification Namesuture, nonabsorbable, synthetic, polyethylene
Generic Namenonabsorbable surgical sutures polypropylene
Regulation Number878.5000
ApplicantHOWMEDICA CORP.
PMA NumberP810028
Supplement NumberS001
Date Received04/26/1983
Decision Date06/22/1983
Product Code
GAT[ Registered Establishments with GAT ]
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product No
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