The following data is part of a premarket notification filed by Salter Labs with the FDA for Salter Labs Single Patient Use Exhalation Aerosol Filter.
| Device ID | K992986 |
| 510k Number | K992986 |
| Device Name: | SALTER LABS SINGLE PATIENT USE EXHALATION AEROSOL FILTER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | SALTER LABS 100 WEST SYCAMORE RD. Arvin, CA 93203 |
| Contact | Duane Kazal |
| Correspondent | Duane Kazal SALTER LABS 100 WEST SYCAMORE RD. Arvin, CA 93203 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-03 |
| Decision Date | 1999-09-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00607411940699 | K992986 | 000 |
| 10607411890564 | K992986 | 000 |
| 20607411890554 | K992986 | 000 |