The following data is part of a premarket notification filed by Spinal Specialties, Inc. with the FDA for Spinal Specialties Nerve Block Tray.
Device ID | K960100 |
510k Number | K960100 |
Device Name: | SPINAL SPECIALTIES NERVE BLOCK TRAY |
Classification | Anesthesia Conduction Kit |
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 | CAZ |
CFR Regulation Number | 868.5140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-01-11 |
Decision Date | 1996-04-24 |