The following data is part of a premarket notification filed by Airway Management Inc. with the FDA for Tap-t.
| Device ID | K061732 |
| 510k Number | K061732 |
| Device Name: | TAP-T |
| Classification | Device, Anti-snoring |
| Applicant | AIRWAY MANAGEMENT INC. 6116 NORTH CENTRAL EXPRESSWAY SUITE 605 Dallas, TX 75206 |
| Contact | Darren Henderson |
| Correspondent | Darren Henderson AIRWAY MANAGEMENT INC. 6116 NORTH CENTRAL EXPRESSWAY SUITE 605 Dallas, TX 75206 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-20 |
| Decision Date | 2006-07-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D745TAP0 | K061732 | 000 |
| 00851085006216 | K061732 | 000 |
| 00851085006209 | K061732 | 000 |