The following data is part of a premarket notification filed by Rondex Products, Inc. with the FDA for Rondex Rescue Mask.
| Device ID | K881393 |
| 510k Number | K881393 |
| Device Name: | RONDEX RESCUE MASK |
| Classification | Mask, Gas, Anesthetic |
| 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 | BSJ |
| CFR Regulation Number | 868.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-04 |
| Decision Date | 1988-04-25 |