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 |