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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name knife, surgical
510(k) Number K880094
Device Name VAN-TEC ENDOPYELOTOMY KNIFE
Applicant
VAN-TEC, INC.
P.O. BOX 26
SPENCER,  IN  47460
Applicant Contact VANCE, JR.
Correspondent
VAN-TEC, INC.
P.O. BOX 26
SPENCER,  IN  47460
Correspondent Contact VANCE, JR.
Regulation Number878.4800
Classification Product Code
EMF  
Date Received01/12/1988
Decision Date 02/29/1988
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
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