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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 K882303
Device Name H&M ANTI-SNORING DEVICE
Applicant
Hays & Meade, Inc.
P.O. Box 25565
Albuquerque,  NM  87125
Applicant Contact ROBERT N SINGER
Correspondent
Hays & Meade, Inc.
P.O. Box 25565
Albuquerque,  NM  87125
Correspondent Contact ROBERT N SINGER
Regulation Number872.5570
Classification Product Code
LRK  
Date Received06/03/1988
Decision Date 04/14/1989
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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