PROSTATIC ASPIRATION BIOPSY SET

Instrument, Biopsy

VAN-TEC, INC.

The following data is part of a premarket notification filed by Van-tec, Inc. with the FDA for Prostatic Aspiration Biopsy Set.

Pre-market Notification Details

Device IDK870735
510k NumberK870735
Device Name:PROSTATIC ASPIRATION BIOPSY SET
ClassificationInstrument, Biopsy
Applicant VAN-TEC, INC. P.O. BOX 26 Spencer,  IN  47460
ContactJames F Vance
CorrespondentJames F Vance
VAN-TEC, INC. P.O. BOX 26 Spencer,  IN  47460
Product CodeKNW  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-02-25
Decision Date1987-03-25

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