Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)

Instrument, Biopsy

MEDAX S.R.L. UNIPERSONALE

The following data is part of a premarket notification filed by Medax S.r.l. Unipersonale with the FDA for Medax Biopsy Systems Ii (medone, Medcut, Medem, Medbone, Medlock).

Pre-market Notification Details

Device IDK172344
510k NumberK172344
Device Name:Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)
ClassificationInstrument, Biopsy
Applicant MEDAX S.R.L. UNIPERSONALE Via R. Piva 1/A Poggio Rusco,  IT 46025
ContactStefano Cavalieri
CorrespondentMario Gennari
Gemar S.r.l. Via G. Puccini 1 Medolla,  IT I-41036
Product CodeKNW  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-08-02
Decision Date2017-11-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
18056772675914 K172344 000
18052286424345 K172344 000
18052286424338 K172344 000
18052286424949 K172344 000
18053329371367 K172344 000
18052286424031 K172344 000
18052286423973 K172344 000
18052283958980 K172344 000
18059174748644 K172344 000
18052286424239 K172344 000
18052286424246 K172344 000
18052286423614 K172344 000
18052283955699 K172344 000
08052283955685 K172344 000
18052283959123 K172344 000
18052283958997 K172344 000
18052283958973 K172344 000
18052286423645 K172344 000
18052286423638 K172344 000
18052286423621 K172344 000
18059174748651 K172344 000

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