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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 K895189
Device Name ADJUSTABLE SOFT PALATE LIFTER
Applicant
ORTHO PUBLICATIONS, INC.
1040 WYANDOTTE TRAIL
WESTFIELD,  NJ  07090
Applicant Contact PASKOW, DDS
Correspondent
ORTHO PUBLICATIONS, INC.
1040 WYANDOTTE TRAIL
WESTFIELD,  NJ  07090
Correspondent Contact PASKOW, DDS
Regulation Number872.5570
Classification Product Code
LRK  
Date Received08/11/1989
Decision Date 02/09/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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