NON-ABSORBABLE SURGICAL SUTURES

Suture, Nonabsorbable, Synthetic, Polyamide

ALCON LABORATORIES

The following data is part of a premarket notification filed by Alcon Laboratories with the FDA for Non-absorbable Surgical Sutures.

Pre-market Notification Details

Device IDK930517
510k NumberK930517
Device Name:NON-ABSORBABLE SURGICAL SUTURES
ClassificationSuture, Nonabsorbable, Synthetic, Polyamide
Applicant ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth,  TX  76134 -2099
ContactDavid Krapf
CorrespondentDavid Krapf
ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth,  TX  76134 -2099
Product CodeGAR  
CFR Regulation Number878.5020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-02-01
Decision Date1993-12-17

NIH GUDID Devices

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