The following data is part of a premarket notification filed by Inspiron Corp. with the FDA for Inspiron Double Swivel Trach Adapter.
| Device ID | K860838 |
| 510k Number | K860838 |
| Device Name: | INSPIRON DOUBLE SWIVEL TRACH ADAPTER |
| Classification | Connector, Airway (extension) |
| Applicant | INSPIRON CORP. 8600 ARCHIBALD AVE. Rancho Cucamonga, CA 91730 |
| Contact | Teresita Awit |
| Correspondent | Teresita Awit INSPIRON CORP. 8600 ARCHIBALD AVE. Rancho Cucamonga, CA 91730 |
| Product Code | BZA |
| CFR Regulation Number | 868.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-05 |
| Decision Date | 1986-04-09 |