The following data is part of a premarket notification filed by Radionics, A Division Of Tyco Healthcare Group Lp with the FDA for Radionics Nashold Biopsy Needle - Single Use.
Device ID | K032054 |
510k Number | K032054 |
Device Name: | RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE |
Classification | Neurological Stereotaxic Instrument |
Applicant | RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP 22 TERRY AVE. Burlington, MA 01803 |
Contact | Kevin J O'connell |
Correspondent | Kevin J O'connell RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP 22 TERRY AVE. Burlington, MA 01803 |
Product Code | HAW |
CFR Regulation Number | 882.4560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-07-02 |
Decision Date | 2003-09-15 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
M248CRWBP1 | K032054 | 000 |
M248RTNBND761 | K032054 | 000 |
M248RTNBND1161 | K032054 | 000 |
M248GT271601 | K032054 | 000 |
M248GT321161 | K032054 | 000 |
M433GT321601 | K032054 | 000 |
M248GT32761 | K032054 | 000 |
M433GT461161 | K032054 | 000 |
M433RTNBND1601 | K032054 | 000 |
30381780252591 | K032054 | 000 |
M248NBND1 | K032054 | 000 |