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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 K072644
Device Name UNICRYL QUICK
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
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