The following data is part of a premarket notification filed by Salter Labs with the FDA for Salter Labs Model #1015.
| Device ID | K903539 |
| 510k Number | K903539 |
| Device Name: | SALTER LABS MODEL #1015 |
| Classification | Device, Fixation, Tracheal Tube |
| Applicant | SALTER LABS P.O. BOX 608 Arvin, CA 93203 |
| Contact | James N Clurti |
| Correspondent | James N Clurti SALTER LABS P.O. BOX 608 Arvin, CA 93203 |
| Product Code | CBH |
| CFR Regulation Number | 868.5770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-07 |
| Decision Date | 1990-12-17 |