The following data is part of a premarket notification filed by Kyphon, Inc. with the FDA for Discyphor Direct Catheter System, Discyphor Direct Needles, Long, Discyphor Direct Needles, Regular.
| Device ID | K073516 |
| 510k Number | K073516 |
| Device Name: | DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | KYPHON, INC. 1221 CROSSMAN AVE. Sunnyvale, CA 94089 |
| Contact | Pamela Segale |
| Correspondent | Pamela Segale KYPHON, INC. 1221 CROSSMAN AVE. Sunnyvale, CA 94089 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-14 |
| Decision Date | 2008-02-21 |
| Summary: | summary |