The following data is part of a premarket notification filed by Anago, Inc. with the FDA for Anago Continuous Epidural Anesthesia Tray/kit.
Device ID | K920615 |
510k Number | K920615 |
Device Name: | ANAGO CONTINUOUS EPIDURAL ANESTHESIA TRAY/KIT |
Classification | Anesthesia Conduction Kit |
Applicant | ANAGO, INC. 7524 MOSIER VIEW CT. Fort Worth, TX 76118 |
Contact | Jill D Albritton |
Correspondent | Jill D Albritton ANAGO, INC. 7524 MOSIER VIEW CT. Fort Worth, TX 76118 |
Product Code | CAZ |
CFR Regulation Number | 868.5140 [🔎] |
Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-02-11 |
Decision Date | 1993-03-20 |