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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Jaw Repositioning
510(k) Number K946112
Device Name ELASTOMERIC SLEEP APPLIANCE
Applicant
Village Park Orthodontics
16 Suffield Ave.
Depew,  NY  14043
Applicant Contact STEPHEN P WARUNEK
Correspondent
Village Park Orthodontics
16 Suffield Ave.
Depew,  NY  14043
Correspondent Contact STEPHEN P WARUNEK
Regulation Number872.5570
Classification Product Code
LQZ  
Date Received12/15/1994
Decision Date 06/14/1995
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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