The following data is part of a premarket notification filed by Dental Imagineers, Llc with the FDA for Snore-aid Max.
Device ID | K022284 |
510k Number | K022284 |
Device Name: | SNORE-AID MAX |
Classification | Device, Anti-snoring |
Applicant | DENTAL IMAGINEERS, LLC 804 WEST PARK AVE. Ocean, NJ 07712 |
Contact | William A Belfer |
Correspondent | William A Belfer DENTAL IMAGINEERS, LLC 804 WEST PARK AVE. Ocean, NJ 07712 |
Product Code | LRK |
CFR Regulation Number | 872.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-07-15 |
Decision Date | 2002-12-10 |
Summary: | summary |