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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, Polypropylene
510(k) Number K961389
Device Name POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES
Applicant
R. K. Medical L. L. C.
One Lethbridge Plaza
Suite 4
Mahwah,  NJ  07430
Applicant Contact BRENDA M KELLY
Correspondent
R. K. Medical L. L. C.
One Lethbridge Plaza
Suite 4
Mahwah,  NJ  07430
Correspondent Contact BRENDA M KELLY
Regulation Number878.5010
Classification Product Code
GAW  
Date Received04/10/1996
Decision Date 06/18/1996
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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