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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 K181571
Device Name OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor
Mark Abramson, D.D.S., Inc
35 Renato Court
redwood city,  CA  94061
Applicant Contact mark abramson
FisherMed Consulting LLC
820 Civic Center Drive
santa clara,  CA  95050
Correspondent Contact cheryl fisher
Regulation Number872.5570
Classification Product Code
Date Received06/14/2018
Decision Date 04/19/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No