The following data is part of a premarket notification filed by Ortho Development Corp. with the FDA for Orion Medical Inc. Disposable Brain Biopsy Needle For Sterotactic Guided Biopsy.
| Device ID | K974158 |
| 510k Number | K974158 |
| Device Name: | ORION MEDICAL INC. DISPOSABLE BRAIN BIOPSY NEEDLE FOR STEROTACTIC GUIDED BIOPSY |
| Classification | Instrument, Biopsy |
| Applicant | ORTHO DEVELOPMENT CORP. 106 WEST 12200 SOUTH Draper, UT 84020 |
| Contact | Carol Frasier |
| Correspondent | Carol Frasier ORTHO DEVELOPMENT CORP. 106 WEST 12200 SOUTH Draper, UT 84020 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-03 |
| Decision Date | 1997-12-09 |
| Summary: | summary |