MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMATIC BIOPSY INSTRUMENT

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 Meical Device Technologies, Inc. Tru-core Disposable Automatic Biopsy Instrument.

Pre-market Notification Details

Device IDK982960
510k NumberK982960
Device Name:MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMATIC BIOPSY INSTRUMENT
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 Received1998-08-24
Decision Date1998-09-23
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.