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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Positive Airway Pressure System
510(k) Number K200698
Device Name Somnera System
Applicant
Fresca Medical, Inc.
1291 Puerta Del Sol Suite #200
San Clemente,  CA  92673
Applicant Contact Mary Lou Mooney
Correspondent
Fresca Medical, Inc.
1291 Puerta Del Sol Suite #200
San Clemente,  CA  92673
Correspondent Contact Mary Lou Mooney
Regulation Number868.5273
Classification Product Code
QBY  
Date Received03/17/2020
Decision Date 06/29/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT03999944
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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