POLYVIOLENE SURGICL SUTURE

Suture, Nonabsorbable, Synthetic, Polyethylene

LOOK, INC.

The following data is part of a premarket notification filed by Look, Inc. with the FDA for Polyviolene Surgicl Suture.

Pre-market Notification Details

Device IDK943949
510k NumberK943949
Device Name:POLYVIOLENE SURGICL SUTURE
ClassificationSuture, Nonabsorbable, Synthetic, Polyethylene
Applicant LOOK, INC. 2020 LONNIE ABBOTT IND. BLVD. Ada,  OK  74820
ContactGary Ainsworth
CorrespondentGary Ainsworth
LOOK, INC. 2020 LONNIE ABBOTT IND. BLVD. Ada,  OK  74820
Product CodeGAT  
CFR Regulation Number878.5000 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-08-02
Decision Date1994-11-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.