The following data is part of a premarket notification filed by Kondex Products, Inc. with the FDA for Rondex Cpr Valve.
| Device ID | K855218 |
| 510k Number | K855218 |
| Device Name: | RONDEX CPR VALVE |
| Classification | Valve, Non-rebreathing |
| Applicant | KONDEX PRODUCTS, INC. P.O. BOX NO 1829 Rockford, IL 61110 |
| Contact | Gene R Baldwin |
| Correspondent | Gene R Baldwin KONDEX PRODUCTS, INC. P.O. BOX NO 1829 Rockford, IL 61110 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-30 |
| Decision Date | 1986-02-12 |