The following data is part of a premarket notification filed by Salter Labs with the FDA for Oxygen Cannula Ear Wrap (style A).
| Device ID | K863431 |
| 510k Number | K863431 |
| Device Name: | OXYGEN CANNULA EAR WRAP (STYLE A) |
| Classification | Cannula, Nasal, Oxygen |
| Applicant | SALTER LABS P.O. BOX 608 Arvin, CA 93203 |
| Contact | James N Curti |
| Correspondent | James N Curti SALTER LABS P.O. BOX 608 Arvin, CA 93203 |
| Product Code | CAT |
| CFR Regulation Number | 868.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-04 |
| Decision Date | 1986-09-18 |