The following data is part of a premarket notification filed by Plasco, Inc. with the FDA for Cpr Microshield Ii.
| Device ID | K950770 |
| 510k Number | K950770 |
| Device Name: | CPR MICROSHIELD II |
| 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 | 1995-02-21 |
| Decision Date | 1995-03-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50748426121248 | K950770 | 000 |
| 50748426074162 | K950770 | 000 |
| 50748426076906 | K950770 | 000 |
| 50748426120333 | K950770 | 000 |
| 50748426120340 | K950770 | 000 |
| 50748426120357 | K950770 | 000 |
| 50748426120364 | K950770 | 000 |
| 50748426121057 | K950770 | 000 |
| 50748426121095 | K950770 | 000 |
| 50748426121101 | K950770 | 000 |
| 50748426121149 | K950770 | 000 |
| 50748426121170 | K950770 | 000 |
| 30748426121183 | K950770 | 000 |
| 30748426121190 | K950770 | 000 |
| 30748426121206 | K950770 | 000 |
| 30748426121213 | K950770 | 000 |
| 50748426121224 | K950770 | 000 |
| 50748426121231 | K950770 | 000 |
| 50748426074155 | K950770 | 000 |