MANAN(TM) SUPER-CORE BIOPSY NEEDLES

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 Manan(tm) Super-core Biopsy Needles.

Pre-market Notification Details

Device IDK974814
510k NumberK974814
Device Name:MANAN(TM) SUPER-CORE BIOPSY NEEDLES
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 Received1997-12-23
Decision Date1998-01-09
Summary:summary

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