The following data is part of a premarket notification filed by Cadema Medical Products, Inc. with the FDA for Disposable Face Mask.
Device ID | K896773 |
510k Number | K896773 |
Device Name: | DISPOSABLE FACE MASK |
Classification | Mask, Oxygen |
Applicant | CADEMA MEDICAL PRODUCTS, INC. P.O. BOX 250 Middletown, NY 10940 |
Contact | Kathleen D Bordoni |
Correspondent | Kathleen D Bordoni CADEMA MEDICAL PRODUCTS, INC. P.O. BOX 250 Middletown, NY 10940 |
Product Code | BYG |
CFR Regulation Number | 868.5580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-12-01 |
Decision Date | 1990-01-12 |