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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, natural
510(k) Number K042287
Device Name UNIPLAIN & UNICHROM
Applicant
UNITED MEDICAL INDUSTRIES CO. LTD.
P.O. BOX 51871
RIYADH, CENTRAL PROVINCE,  SA 11553
Applicant Contact MOHAMMED AZEEZ
Correspondent
UNITED MEDICAL INDUSTRIES CO. LTD.
P.O. BOX 51871
RIYADH, CENTRAL PROVINCE,  SA 11553
Correspondent Contact MOHAMMED AZEEZ
Regulation Number878.4830
Classification Product Code
GAL  
Date Received08/24/2004
Decision Date 09/07/2005
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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