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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Nonabsorbable, Synthetic, Polyamide
510(k) Number K930943
Device Name LUKENS NYLON SURGICAL SUTURE
Applicant
Lukens Medical Corp.
The Lahr Consulting Group,Inc.
One Lethbridge Plz.
Mahwah,  NJ  07430
Applicant Contact BRENDA KELLY
Correspondent
Lukens Medical Corp.
The Lahr Consulting Group,Inc.
One Lethbridge Plz.
Mahwah,  NJ  07430
Correspondent Contact BRENDA KELLY
Regulation Number878.5020
Classification Product Code
GAR  
Date Received02/23/1993
Decision Date 12/17/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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