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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, Polyethylene
510(k) Number K961925
Device Name POLYESTER NONABSORBABLE SURGICAL SUTURES USP
Applicant
R. K. Medical L. L. C.
One Lethbridge Plz.
Suite 4
Mahwah,  NJ  07430
Applicant Contact BRENDA M KELLY, M.D.
Correspondent
R. K. Medical L. L. C.
One Lethbridge Plz.
Suite 4
Mahwah,  NJ  07430
Correspondent Contact BRENDA M KELLY, M.D.
Regulation Number878.5000
Classification Product Code
GAT  
Date Received05/17/1996
Decision Date 07/29/1996
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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