The following data is part of a premarket notification filed by Spinal Specialties, Inc. with the FDA for Continuous Epidural Anesthesia Tray.
Device ID | K944029 |
510k Number | K944029 |
Device Name: | CONTINUOUS EPIDURAL ANESTHESIA TRAY |
Classification | Anesthesia Conduction Kit |
Applicant | SPINAL SPECIALTIES, INC. 4230 CENTERGATE San Antonio, TX 78217 |
Contact | Robert Keahey |
Correspondent | Robert Keahey SPINAL SPECIALTIES, INC. 4230 CENTERGATE San Antonio, TX 78217 |
Product Code | CAZ |
CFR Regulation Number | 868.5140 [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-08-17 |
Decision Date | 1995-06-30 |