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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, non-continuous (respirator)
510(k) Number K130686
Device Name NASAL COMFORT FREEDOM
Applicant
LAKEVIEW SLEEP CENTER
400 NORTH RAND RD
NORTH BARRINGTON,  IL  60010
Applicant Contact ANDY BLACK
Correspondent
LAKEVIEW SLEEP CENTER
400 NORTH RAND RD
NORTH BARRINGTON,  IL  60010
Correspondent Contact ANDY BLACK
Regulation Number868.5905
Classification Product Code
BZD  
Date Received03/13/2013
Decision Date 10/16/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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