The following data is part of a premarket notification filed by Portex, Inc. with the FDA for Continuous Epidural Anesthesia Tray.
Device ID | K781052 |
510k Number | K781052 |
Device Name: | CONTINUOUS EPIDURAL ANESTHESIA TRAY |
Classification | Anesthesia Conduction Kit |
Applicant | PORTEX, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CAZ |
CFR Regulation Number | 868.5140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-06-22 |
Decision Date | 1978-08-02 |