The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Epidural Anesthesia Tray.
Device ID | K860833 |
510k Number | K860833 |
Device Name: | EPIDURAL ANESTHESIA TRAY |
Classification | Anesthesia Conduction Kit |
Applicant | TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
Contact | Thomas D Nickel |
Correspondent | Thomas D Nickel TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
Product Code | CAZ |
CFR Regulation Number | 868.5140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-03-05 |
Decision Date | 1986-04-17 |