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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 K170692
Device Name Respire Pink Series with DentiTrac
Applicant
Respire Medical Holding
18 Bridge St., Suite 4j
Brooklyn,  NY  11201
Applicant Contact Jonathan Sandler
Correspondent
Respire Medical Holding
18 Bridge St., Suite 4j
Brooklyn,  NY  11201
Correspondent Contact Jonathan Sandler
Regulation Number872.5570
Classification Product Code
LRK  
Subsequent Product Code
PLC  
Date Received03/07/2017
Decision Date 05/26/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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