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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Surgical, Absorbable, Polydioxanone
510(k) Number K042285
Device Name UNICRYL M
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 Number878.4840
Classification Product Code
NEW  
Date Received08/24/2004
Decision Date 12/10/2004
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
Predetermined Change
Control Plan Authorized		 No
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