The following data is part of a premarket notification filed by Anago, Inc. with the FDA for Anti-for Surgical Face Mask.
Device ID | K905865 |
510k Number | K905865 |
Device Name: | ANTI-FOR SURGICAL FACE MASK |
Classification | Mask, Surgical |
Applicant | ANAGO, INC. 7524 MOSIER VIEW CT. Fort Worth, TX 76118 |
Contact | Steven R Robinson |
Correspondent | Steven R Robinson 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 | 1990-12-24 |
Decision Date | 1991-03-06 |