The following data is part of a premarket notification filed by Plasco, Inc. with the FDA for Cpr Micromask.
Device ID | K951483 |
510k Number | K951483 |
Device Name: | CPR MICROMASK |
Classification | Valve, Non-rebreathing |
Applicant | PLASCO, INC. 4080 MORRISON DR. Gurnee, IL 60031 |
Contact | Gary S Botsford |
Correspondent | Gary S Botsford PLASCO, INC. 4080 MORRISON DR. Gurnee, IL 60031 |
Product Code | CBP |
CFR Regulation Number | 868.5870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-03-30 |
Decision Date | 1995-10-19 |