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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, Steel, Monofilament And Multifilament, Sterile
510(k) Number K930740
Device Name SURGICAL SUTURE, NONABSORABLE STAINLESS STEEL
Applicant
DEKNATEL, INC.
KILOMETER 9 CARRETERA
SAN JOSE-HEREDIA,  CR
Applicant Contact HARRY C SAVARD
Correspondent
DEKNATEL, INC.
KILOMETER 9 CARRETERA
SAN JOSE-HEREDIA,  CR
Correspondent Contact HARRY C SAVARD
Regulation Number878.4495
Classification Product Code
GAQ  
Date Received02/12/1993
Decision Date 07/26/1994
Decision Substantially Equivalent (SESE)
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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