LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P.

Suture, Absorbable, Synthetic, Polyglycolic Acid

LUKENS MEDICAL CORP.

The following data is part of a premarket notification filed by Lukens Medical Corp. with the FDA for Lukens Pga, (polyglycolic Acid) Synthetic Absorbable Surgical Suture,coated, Braided-u.s.p..

Pre-market Notification Details

Device IDK965162
510k NumberK965162
Device Name:LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P.
ClassificationSuture, Absorbable, Synthetic, Polyglycolic Acid
Applicant LUKENS MEDICAL CORP. THE LAHR CONSULTING GROUP,INC. ONE LETHBRIDGE PLAZA Mahwah,  NJ  07430
ContactBrenda M Kelly
CorrespondentBrenda M Kelly
LUKENS MEDICAL CORP. THE LAHR CONSULTING GROUP,INC. ONE LETHBRIDGE PLAZA Mahwah,  NJ  07430
Product CodeGAM  
CFR Regulation Number878.4493 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-12-24
Decision Date1997-02-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D6620712443590 K965162 000
D66207124434209 K965162 000
D6620712443340 K965162 000
D6620712443180 K965162 000

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