The following data is part of a premarket notification filed by Rondex Products, Inc. with the FDA for Non-breathing Valve.
| Device ID | K943761 |
| 510k Number | K943761 |
| Device Name: | NON-BREATHING VALVE |
| Classification | Valve, Non-rebreathing |
| Applicant | RONDEX PRODUCTS, INC. P.O. BOX NO. 1829 Rockford, IL 61110 |
| Contact | Gene R Baldwin |
| Correspondent | Gene R Baldwin RONDEX PRODUCTS, INC. P.O. BOX NO. 1829 Rockford, IL 61110 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-02 |
| Decision Date | 1994-11-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06343760914021 | K943761 | 000 |
| 06343760091432 | K943761 | 000 |
| 06343760091401 | K943761 | 000 |
| 06343760040409 | K943761 | 000 |