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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retention Device, Suture
510(k) Number K904435
Device Name VENTROFIL TENSION RELIEF SUTURE SET
Applicant
Aesculap, Inc.
875 Stanton Rd.
Burlingame,  CA  94010
Applicant Contact ROBIN BUSH
Correspondent
Aesculap, Inc.
875 Stanton Rd.
Burlingame,  CA  94010
Correspondent Contact ROBIN BUSH
Regulation Number878.4930
Classification Product Code
KGS  
Date Received09/28/1990
Decision Date 08/29/1991
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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