The following data is part of a premarket notification filed by Anago, Inc. with the FDA for Disposable Pillow.
Device ID | K810264 |
510k Number | K810264 |
Device Name: | DISPOSABLE PILLOW |
Classification | Bedding, Disposable, Medical |
Applicant | ANAGO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KME |
CFR Regulation Number | 880.6060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-02-02 |
Decision Date | 1981-02-09 |