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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mouthguard, migraine/tension headache
510(k) Number K160477
Device Name The Luco Hybrid OSA Appliance
Applicant
LUCO HYBRID OSA APPLIANCE INC.
1419 BUTTERNUT CREEK ROAD
KINGSTON,  CA K7L 4V3
Applicant Contact Ken Luco
Correspondent
LUCO HYBRID OSA APPLIANCE INC.
1419 BUTTERNUT CREEK ROAD
KINGSTON,  CA K7L 4V3
Correspondent Contact Ken Luco
Classification Product Code
OCO  
Date Received02/19/2016
Decision Date 07/29/2016
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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