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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 K153387
Device Name Luna CPAP and Auto CPAP System
Applicant
3B Medical, Inc.
21301 Hwy. 27
Lake Wales,  FL  33859
Applicant Contact ALEX LUCIO
Correspondent
3B Medical, Inc.
21301 Hwy. 27
Lake Wales,  FL  33859
Correspondent Contact ALEX LUCIO
Regulation Number868.5905
Classification Product Code
BZD  
Date Received11/23/2015
Decision Date 09/08/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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