LUKENS NYLON SURGICAL SUTURE

Suture, Nonabsorbable, Synthetic, Polyamide

LUKENS MEDICAL CORP.

The following data is part of a premarket notification filed by Lukens Medical Corp. with the FDA for Lukens Nylon Surgical Suture.

Pre-market Notification Details

Device IDK930943
510k NumberK930943
Device Name:LUKENS NYLON SURGICAL SUTURE
ClassificationSuture, Nonabsorbable, Synthetic, Polyamide
Applicant LUKENS MEDICAL CORP. THE LAHR CONSULTING GROUP,INC. ONE LETHBRIDGE PLAZA Mahwah,  NJ  07430
ContactBrenda Kelly
CorrespondentBrenda Kelly
LUKENS MEDICAL CORP. THE LAHR CONSULTING GROUP,INC. ONE LETHBRIDGE PLAZA Mahwah,  NJ  07430
Product CodeGAR  
CFR Regulation Number878.5020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-02-23
Decision Date1993-12-17

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