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 |