The following data is part of a premarket notification filed by Parallax Medical, Inc. with the FDA for Clearview Plus Bone And Vertebral Body Biopsy Needles.
| Device ID | K022169 |
| 510k Number | K022169 |
| Device Name: | CLEARVIEW PLUS BONE AND VERTEBRAL BODY BIOPSY NEEDLES |
| Classification | Instrument, Biopsy |
| Applicant | PARALLAX MEDICAL, INC. 940 DISC DR. Scotts Valley, CA 95066 -4544 |
| Contact | Richard M Ruedy |
| Correspondent | Richard M Ruedy PARALLAX MEDICAL, INC. 940 DISC DR. Scotts Valley, CA 95066 -4544 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-03 |
| Decision Date | 2002-07-25 |
| Summary: | summary |