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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 K991073
Device Name ACIER SUTURES
Applicant
CARDIO THORACIC SYSTEMS
10600 N. TANTAU AVE.
CUPERTINO,  CA  95014 -0739
Applicant Contact MICHAEL J BILLIG
Correspondent
CARDIO THORACIC SYSTEMS
10600 N. TANTAU AVE.
CUPERTINO,  CA  95014 -0739
Correspondent Contact MICHAEL J BILLIG
Regulation Number878.4495
Classification Product Code
GAQ  
Date Received03/31/1999
Decision Date 07/30/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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