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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 K042288
Device Name UNICRYL
Applicant
UNITED MEDICAL INDUSTRIES CO. LTD.
3RD INDUSTRIAL CITY
SANAYYA, OPPOSITE TO OBAIKAN
RIYADH, CENTRAL PROVINCE,  SA 11553
Applicant Contact MOHAMMED AZEEZ
Correspondent
UNITED MEDICAL INDUSTRIES CO. LTD.
3RD INDUSTRIAL CITY
SANAYYA, OPPOSITE TO OBAIKAN
RIYADH, CENTRAL PROVINCE,  SA 11553
Correspondent Contact MOHAMMED AZEEZ
Regulation Number878.4493
Classification Product Code
GAM  
Date Received08/24/2004
Decision Date 12/27/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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