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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 K181416
Device Name Sapphire Dorsal Comfort Fit
Applicant
Crane Dental Laboratory, Inc
3515 Buffalo Road Suite 30
Rochester,  NY  14624
Applicant Contact Sharlene Schultz
Correspondent
Crane Dental Laboratory, Inc
3515 Buffalo Road Suite 30
Rochester,  NY  14624
Correspondent Contact Sharlene Schultz
Regulation Number872.5570
Classification Product Code
LRK  
Date Received05/31/2018
Decision Date 09/17/2019
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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