REVISED LABELING FOR NYLON SUTURE (POLYAMIDE)

Suture, Nonabsorbable, Synthetic, Polyamide

LOOK, INC.

The following data is part of a premarket notification filed by Look, Inc. with the FDA for Revised Labeling For Nylon Suture (polyamide).

Pre-market Notification Details

Device IDK926587
510k NumberK926587
Device Name:REVISED LABELING FOR NYLON SUTURE (POLYAMIDE)
ClassificationSuture, Nonabsorbable, Synthetic, Polyamide
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 CodeGAR  
CFR Regulation Number878.5020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-12-01
Decision Date1993-12-17

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