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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameSURGILENE
Classification Namesuture, nonabsorbable, synthetic, polyethylene
Generic Namepolypropylene non-absorbable sutures
Regulation Number878.5000
ApplicantDAVIS & GECK, INC.
PMA NumberN17825
Supplement NumberS014
Date Received07/02/1985
Decision Date08/23/1985
Product Code
GAT[ Registered Establishments with GAT ]
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product No
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