The following data is part of a premarket notification filed by Rusch, Inc. with the FDA for Rusch Emergency Mask.
| Device ID | K993528 |
| 510k Number | K993528 |
| Device Name: | RUSCH EMERGENCY MASK |
| Classification | Valve, Non-rebreathing |
| Applicant | RUSCH, INC. 2450 MEADOWBROOK PKWY. Duluth, GA 30096 |
| Contact | Ronald Young |
| Correspondent | Ronald Young RUSCH, INC. 2450 MEADOWBROOK PKWY. Duluth, GA 30096 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-18 |
| Decision Date | 2000-05-31 |
| Summary: | summary |