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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Absorbable, Synthetic, Polyglycolic Acid
510(k) Number K072646
Device Name UNICAPRONE
Applicant
United Medical Industries Co. , Ltd.
3rd Industrial City
P.O. Box 51871
Riyadh, Central Province,  SA 11553
Applicant Contact R RAGHUNATHAN
Correspondent
United Medical Industries Co. , Ltd.
3rd Industrial City
P.O. Box 51871
Riyadh, Central Province,  SA 11553
Correspondent Contact R RAGHUNATHAN
Regulation Number878.4493
Classification Product Code
GAM  
Date Received09/18/2007
Decision Date 11/07/2007
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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