The following data is part of a premarket notification filed by Airway Management Inc. with the FDA for Tap Iii Anti-snoring Device.
Device ID | K062951 |
510k Number | K062951 |
Device Name: | TAP III ANTI-SNORING DEVICE |
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 | 2006-09-29 |
Decision Date | 2006-12-12 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00851085006100 | K062951 | 000 |
00851085006094 | K062951 | 000 |
00851085006087 | K062951 | 000 |
D745TAP30 | K062951 | 000 |