The following data is part of a premarket notification filed by Airway Management Inc. with the FDA for Tap Ii Anti-snoring And Obstructive Sleep Apnea Oral Appliance With Attachment.
| Device ID | K060388 |
| 510k Number | K060388 |
| Device Name: | TAP II ANTI-SNORING AND OBSTRUCTIVE SLEEP APNEA ORAL APPLIANCE WITH ATTACHMENT |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-14 |
| Decision Date | 2006-05-17 |
| Summary: | summary |