The following data is part of a premarket notification filed by Anago, Inc. with the FDA for Anago Warm Pack.
Device ID | K926589 |
510k Number | K926589 |
Device Name: | ANAGO WARM PACK |
Classification | Pack, Hot Or Cold, Disposable |
Applicant | ANAGO, INC. 7524 MOSIER VIEW CT. Fort Worth, TX 76118 |
Contact | Jill D Albritton |
Correspondent | Jill D Albritton ANAGO, INC. 7524 MOSIER VIEW CT. Fort Worth, TX 76118 |
Product Code | IMD |
CFR Regulation Number | 890.5710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-07 |
Decision Date | 1993-05-26 |