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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 K140429
Device Name CRANE ACRYLIC HERBST APPLIANCE
Applicant
CRANE DENTAL LABORATORY, INC.
200 AIRPARK DRIVE, SUITE 30
ROCHESTER,  NY  14624
Applicant Contact KATE YOUNG
Correspondent
CRANE DENTAL LABORATORY, INC.
200 AIRPARK DRIVE, SUITE 30
ROCHESTER,  NY  14624
Correspondent Contact KATE YOUNG
Regulation Number872.5570
Classification Product Code
LRK  
Date Received02/19/2014
Decision Date 09/11/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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