The following data is part of a premarket notification filed by Medsurg Industries, Inc. with the FDA for Continuous Epidural Anesthesia Tray.
Device ID | K893938 |
510k Number | K893938 |
Device Name: | CONTINUOUS EPIDURAL ANESTHESIA TRAY |
Classification | Anesthesia Conduction Kit |
Applicant | MEDSURG INDUSTRIES, INC. 251 EXCHANGE PLACE Herndon, VA 20170 -4822 |
Contact | Thomas Bonner |
Correspondent | Thomas Bonner MEDSURG INDUSTRIES, INC. 251 EXCHANGE PLACE Herndon, VA 20170 -4822 |
Product Code | CAZ |
CFR Regulation Number | 868.5140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-31 |
Decision Date | 1989-08-07 |