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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name suture, nonabsorbable, synthetic, polyamide
510(k) Number K943222
Device Name SURGIDEK S
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 Number878.5020
Classification Product Code
GAR  
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
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