The following data is part of a premarket notification filed by Allergy Control Products, Inc. with the FDA for Allergy Control Covers.
Device ID | K903382 |
510k Number | K903382 |
Device Name: | ALLERGY CONTROL COVERS |
Classification | Cover, Mattress (medical Purposes) |
Applicant | ALLERGY CONTROL PRODUCTS, INC. 96 DANBURY RD. Ridgefield, CT 06877 |
Contact | Annette Miller |
Correspondent | Annette Miller ALLERGY CONTROL PRODUCTS, INC. 96 DANBURY RD. Ridgefield, CT 06877 |
Product Code | FMW |
CFR Regulation Number | 880.6190 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-07-27 |
Decision Date | 1990-11-02 |