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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 K930738
Device Name SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC
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 Number878.4830
Classification Product Code
GAL  
Subsequent Product Codes
GAM   GAP   GAQ   GAR   GAT  
GAW  
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
Recalls CDRH Recalls
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