The following data is part of a premarket notification filed by Kyphon, Inc. with the FDA for Functional Anaesthetic Discography (fad) Catheter System, Model D01a ; Introducer Needle, Model D01b.
| Device ID | K061210 |
| 510k Number | K061210 |
| Device Name: | FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL D01A ; INTRODUCER NEEDLE, MODEL D01B |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | KYPHON, INC. 1221 CROSSMAN AVE. Sunnyvale, CA 94089 |
| Contact | Cindy Domecus |
| Correspondent | Cindy Domecus KYPHON, INC. 1221 CROSSMAN AVE. Sunnyvale, CA 94089 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-01 |
| Decision Date | 2006-06-27 |
| Summary: | summary |