BERAHA BIOPSY NEEDLES, 2N2730, 2N2731 & 2N2732

Instrument, Biopsy

TRAVENOL LABORATORIES, S.A.

The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Beraha Biopsy Needles, 2n2730, 2n2731 & 2n2732.

Pre-market Notification Details

Device IDK855003
510k NumberK855003
Device Name:BERAHA BIOPSY NEEDLES, 2N2730, 2N2731 & 2N2732
ClassificationInstrument, Biopsy
Applicant TRAVENOL LABORATORIES, S.A. Deerfield,  IL  60015
ContactThomas D Nickel
CorrespondentThomas D Nickel
TRAVENOL LABORATORIES, S.A. Deerfield,  IL  60015
Product CodeKNW  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-12-13
Decision Date1986-02-10

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