The following data is part of a premarket notification filed by Spinal Specialties, Inc. with the FDA for Discography Kit.
| Device ID | K960082 |
| 510k Number | K960082 |
| Device Name: | DISCOGRAPHY KIT |
| Classification | System, X-ray, Photofluorographic |
| Applicant | SPINAL SPECIALTIES, INC. 4230 CENTERGATE San Antonio, TX 78217 |
| Contact | Michael Wakely |
| Correspondent | Michael Wakely SPINAL SPECIALTIES, INC. 4230 CENTERGATE San Antonio, TX 78217 |
| Product Code | IZG |
| CFR Regulation Number | 892.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-11 |
| Decision Date | 1996-03-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780262831 | K960082 | 000 |
| 10381780262824 | K960082 | 000 |
| 10381780261247 | K960082 | 000 |