MEDICAL DEVICE TECHNOLOGIES MANUAL BIOPSY NEEDLE

Instrument, Biopsy

MEDICAL DEVICE TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Medical Device Technologies, Inc. with the FDA for Medical Device Technologies Manual Biopsy Needle.

Pre-market Notification Details

Device IDK944837
510k NumberK944837
Device Name:MEDICAL DEVICE TECHNOLOGIES MANUAL BIOPSY NEEDLE
ClassificationInstrument, Biopsy
Applicant MEDICAL DEVICE TECHNOLOGIES, INC. 4445 SW 35TH TERRACE SUITE 310 Gainesville,  FL  32608
ContactKarl Swartz
CorrespondentKarl Swartz
MEDICAL DEVICE TECHNOLOGIES, INC. 4445 SW 35TH TERRACE SUITE 310 Gainesville,  FL  32608
Product CodeKNW  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-09-30
Decision Date1994-10-14

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