510(k) K132506

SLEEPTIGHT MOUTHPIECE, SLEEPPRO, QUIETNITE, ALTITUDE MOUTHPIECE, SLEEP EASY by Michael D Williams Dds PA — Product Code LRK

K132506 is an FDA 510(k) premarket notification submitted by Michael D Williams Dds PA for the device "SLEEPTIGHT MOUTHPIECE, SLEEPPRO, QUIETNITE, ALTITUDE MOUTHPIECE, SLEEP EASY". The FDA issued a decision of Substantially Equivalent on May 29, 2014. The device falls under product code LRK (Device, Anti-Snoring), a Class II device regulated under 21 CFR 872.5570. Michael D Williams Dds PA has 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2014
Date Received
Aug 12, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Anti-Snoring
Device Class
Class II
Regulation Number
872.5570
Review Panel
DE
Submission Type
510(k)