The following data is part of a premarket notification filed by Wet Nose Technologies, Llc with the FDA for Pressure Release Valve W/audible, Model Prv 20/40/60; With T6 Adapter, Model Prv 120/140/160; T6 Adapter, Model T6-100.
| Device ID | K091538 |
| 510k Number | K091538 |
| Device Name: | PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T6 ADAPTER, MODEL PRV 120/140/160; T6 ADAPTER, MODEL T6-100 |
| Classification | Valve, Non-rebreathing |
| Applicant | WET NOSE TECHNOLOGIES, LLC 3750 2ND AVE Los Angeles, CA 90018 |
| Contact | Jim Barley |
| Correspondent | Jim Barley WET NOSE TECHNOLOGIES, LLC 3750 2ND AVE Los Angeles, CA 90018 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-26 |
| Decision Date | 2010-03-25 |
| Summary: | summary |