The following data is part of a premarket notification filed by Passy & Passy, Inc. with the FDA for Passy-muir Tracheostomy Speaking Valve 15mm / 22mm.
| Device ID | K903699 |
| 510k Number | K903699 |
| Device Name: | PASSY-MUIR TRACHEOSTOMY SPEAKING VALVE 15MM / 22MM |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | PASSY & PASSY, INC. 4521 CAMPUS DRIVE, SUITE 273 Irvine, CA 92715 |
| Contact | Patricia E Passy |
| Correspondent | Patricia E Passy PASSY & PASSY, INC. 4521 CAMPUS DRIVE, SUITE 273 Irvine, CA 92715 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-15 |
| Decision Date | 1990-09-04 |