The following data is part of a premarket notification filed by Innospine, Inc. with the FDA for Functional Anaesthetic Discography (fad) System, Including Fad Catheter Kit And Fad Introducer Needle.
| Device ID | K043500 |
| 510k Number | K043500 |
| Device Name: | FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) SYSTEM, INCLUDING FAD CATHETER KIT AND FAD INTRODUCER NEEDLE |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | INNOSPINE, INC. 11240 MAGDALENA ROAD Los Altos Hills, CA 94024 |
| Contact | Laraine Pangelina |
| Correspondent | Laraine Pangelina INNOSPINE, INC. 11240 MAGDALENA ROAD Los Altos Hills, CA 94024 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-20 |
| Decision Date | 2005-04-15 |
| Summary: | summary |