The following data is part of a premarket notification filed by Salter Labs with the FDA for Salter Labs Pep Device.
| Device ID | K991788 |
| 510k Number | K991788 |
| Device Name: | SALTER LABS PEP DEVICE |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-25 |
| Decision Date | 1999-08-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10607411001359 | K991788 | 000 |
| 00607411001345 | K991788 | 000 |
| 10607411001281 | K991788 | 000 |