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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sleep appliances with patient monitoring
510(k) Number K161624
Device Name MicrO2 OSA Device with Micro-Recorder
Applicant
MICRODENTAL, Inc.
5601 Arnold Rd.
Dublin,  CA  94568
Applicant Contact David Kuhns
Correspondent
MICRODENTAL, Inc.
5601 Arnold Rd.
Dublin,  CA  94568
Correspondent Contact David Kuhns
Regulation Number872.5570
Classification Product Code
PLC  
Date Received06/13/2016
Decision Date 11/07/2016
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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