510(k) K062951

TAP III ANTI-SNORING DEVICE by Airway Management, Inc. — Product Code LRK

K062951 is an FDA 510(k) premarket notification submitted by Airway Management, Inc. for the device "TAP III ANTI-SNORING DEVICE". The FDA issued a decision of Substantially Equivalent on December 12, 2006. The device falls under product code LRK (Device, Anti-Snoring), a Class II device regulated under 21 CFR 872.5570. Airway Management, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2006
Date Received
September 29, 2006
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