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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 K943218
Device Name CHROMIC CATGUT
Applicant
SUTURES LTD.
VAUXHALL IND. ESTATE
RUABON, WREXHAM,  GB LL14 6HA
Applicant Contact ELEANOR JONES
Correspondent
SUTURES LTD.
VAUXHALL IND. ESTATE
RUABON, WREXHAM,  GB LL14 6HA
Correspondent Contact ELEANOR JONES
Regulation Number878.4830
Classification Product Code
GAL  
Date Received07/05/1994
Decision Date 12/05/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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