The following data is part of a premarket notification filed by Anago, Inc. with the FDA for Disposable Nurses Cap.
Device ID | K802186 |
510k Number | K802186 |
Device Name: | DISPOSABLE NURSES CAP |
Classification | Cap, Surgical |
Applicant | ANAGO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FYF |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-09-10 |
Decision Date | 1980-09-26 |