ADVANCE SUTURE NONABSORBABLE SILK SUTURE

Suture, Nonabsorbable, Silk

ADVANCE SUTURE, INC.

The following data is part of a premarket notification filed by Advance Suture, Inc. with the FDA for Advance Suture Nonabsorbable Silk Suture.

Pre-market Notification Details

Device IDK905454
510k NumberK905454
Device Name:ADVANCE SUTURE NONABSORBABLE SILK SUTURE
ClassificationSuture, Nonabsorbable, Silk
Applicant ADVANCE SUTURE, INC. P.O. BOX 12428 Tucson,  AZ  85732
ContactDaniel P Misenhimer
CorrespondentDaniel P Misenhimer
ADVANCE SUTURE, INC. P.O. BOX 12428 Tucson,  AZ  85732
Product CodeGAP  
CFR Regulation Number878.5030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-12-05
Decision Date1991-06-28

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