The following data is part of a premarket notification filed by Anago, Inc. with the FDA for Armboard Cver, Disposable.
Device ID | K782092 |
510k Number | K782092 |
Device Name: | ARMBOARD CVER, DISPOSABLE |
Classification | Table, Operating-room, Manual |
Applicant | ANAGO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FSE |
CFR Regulation Number | 878.4950 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-12-14 |
Decision Date | 1979-01-10 |