The following data is part of a premarket notification filed by Anago, Inc. with the FDA for Reliable Cone Style Face Mask.
Device ID | K913558 |
510k Number | K913558 |
Device Name: | RELIABLE CONE STYLE FACE MASK |
Classification | Mask, Surgical |
Applicant | ANAGO, INC. 7524 MOSIER VIEW CT. Fort Worth, TX 76118 |
Contact | Jill Albritton |
Correspondent | Jill Albritton ANAGO, INC. 7524 MOSIER VIEW CT. Fort Worth, TX 76118 |
Product Code | FXX |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-08-09 |
Decision Date | 1991-11-07 |