The following data is part of a premarket notification filed by Healthy Sleep Dental Laboratory with the FDA for Healthy Sleep Appliance.
Device ID | K123410 |
510k Number | K123410 |
Device Name: | HEALTHY SLEEP APPLIANCE |
Classification | Device, Anti-snoring |
Applicant | HEALTHY SLEEP DENTAL LABORATORY 24301 WOODSAGE DR. Bonita Springs, FL 34134 |
Contact | Paul Dryden |
Correspondent | Paul Dryden HEALTHY SLEEP DENTAL LABORATORY 24301 WOODSAGE DR. Bonita Springs, FL 34134 |
Product Code | LRK |
CFR Regulation Number | 872.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-11-05 |
Decision Date | 2013-04-05 |
Summary: | summary |