The following data is part of a premarket notification filed by Formosa-cj Health Business Corp. with the FDA for Cpr Super Pocket Pack.
| Device ID | K953230 |
| 510k Number | K953230 |
| Device Name: | CPR SUPER POCKET PACK |
| Classification | Valve, Non-rebreathing |
| Applicant | FORMOSA-CJ HEALTH BUSINESS CORP. 6329 W. WATERVIEW CT. Mccordsville, IN 46055 -9501 |
| Contact | Paul E Dryden |
| Correspondent | Paul E Dryden FORMOSA-CJ HEALTH BUSINESS CORP. 6329 W. WATERVIEW CT. Mccordsville, IN 46055 -9501 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-10 |
| Decision Date | 1996-02-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 44710810080386 | K953230 | 000 |