The following data is part of a premarket notification filed by Plasco, Inc. with the FDA for Cpr Micromask With Oxygen Inlet.
| Device ID | K953414 |
| 510k Number | K953414 |
| Device Name: | CPR MICROMASK WITH OXYGEN INLET |
| 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 | 1995-07-20 |
| Decision Date | 1996-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50748426075176 | K953414 | 000 |
| 50748426075169 | K953414 | 000 |
| 50748426075145 | K953414 | 000 |