The following data is part of a premarket notification filed by Spinal Specialties, Inc. with the FDA for Epidural Needle.
Device ID | K942863 |
510k Number | K942863 |
Device Name: | EPIDURAL NEEDLE |
Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
Applicant | SPINAL SPECIALTIES, INC. 4230 CENTERGATE San Antonio, TX 78217 |
Contact | Robert Keahney |
Correspondent | Robert Keahney SPINAL SPECIALTIES, INC. 4230 CENTERGATE San Antonio, TX 78217 |
Product Code | BSP |
CFR Regulation Number | 868.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-06-17 |
Decision Date | 1995-08-11 |