510(k) K060388

TAP II ANTI-SNORING AND OBSTRUCTIVE SLEEP APNEA ORAL APPLIANCE WITH ATTACHMENT by Airway Management, Inc. — Product Code LRK

K060388 is an FDA 510(k) premarket notification submitted by Airway Management, Inc. for the device "TAP II ANTI-SNORING AND OBSTRUCTIVE SLEEP APNEA ORAL APPLIANCE WITH ATTACHMENT". The FDA issued a decision of Substantially Equivalent on May 17, 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.