The following data is part of a premarket notification filed by The Snore Reliever Company Llc with the FDA for Vital Sleep.
Device ID | K092942 |
510k Number | K092942 |
Device Name: | VITAL SLEEP |
Classification | Device, Anti-snoring |
Applicant | THE SNORE RELIEVER COMPANY LLC 28711 JAEGER DRIVE Laguna Niguel, CA 92677 |
Contact | Nicolaas Besseling |
Correspondent | Nicolaas Besseling THE SNORE RELIEVER COMPANY LLC 28711 JAEGER DRIVE Laguna Niguel, CA 92677 |
Product Code | LRK |
CFR Regulation Number | 872.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-09-24 |
Decision Date | 2010-01-13 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00850072689012 | K092942 | 000 |
00850072689005 | K092942 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() VITAL SLEEP 85760282 not registered Dead/Abandoned |
Healthy Directions, LLC 2012-10-22 |
![]() VITAL SLEEP 77792613 3890953 Live/Registered |
The Snore Reliever Company LLC 2009-07-29 |