The following data is part of a premarket notification filed by Plasco, Inc. with the FDA for Cpr Micromask.
Device ID | K943386 |
510k Number | K943386 |
Device Name: | CPR MICROMASK |
Classification | Device, Cpr Assist |
Applicant | PLASCO, INC. 3849 SWANSON ST. Gurnee, IL 60031 -1225 |
Contact | Gary S Botsford |
Correspondent | Gary S Botsford PLASCO, INC. 3849 SWANSON ST. Gurnee, IL 60031 -1225 |
Product Code | LYM |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-07-13 |
Decision Date | 1995-02-21 |