The following data is part of a premarket notification filed by Parallax Medical, Inc. with the FDA for Parallax Bone And Vertebral Body Biopsy And Infusion Needles.
| Device ID | K011206 |
| 510k Number | K011206 |
| Device Name: | PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-19 |
| Decision Date | 2001-07-18 |