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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Anti-Snoring
510(k) Number K950763
Device Name LOWE KLEARWAY
Applicant
Dr. Alan A. Lowe, Inc.
Suite 103
2786 W. 16th Ave.
Vancouver, B.C. V6k 4m1,  CA V6K 4M1
Applicant Contact ALAN A LOWE
Correspondent
Dr. Alan A. Lowe, Inc.
Suite 103
2786 W. 16th Ave.
Vancouver, B.C. V6k 4m1,  CA V6K 4M1
Correspondent Contact ALAN A LOWE
Regulation Number872.5570
Classification Product Code
LRK  
Date Received02/17/1995
Decision Date 05/25/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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