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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 K130828
Device Name K SERIES CPAP SYSTEMS
Applicant
Curative Medical, Inc.
6518 Tamarind Sky Ln.
Fulshear,  TX  77441
Applicant Contact AMY MCKINNEY
Correspondent
Curative Medical, Inc.
6518 Tamarind Sky Ln.
Fulshear,  TX  77441
Correspondent Contact AMY MCKINNEY
Regulation Number868.5905
Classification Product Code
BZD  
Date Received03/26/2013
Decision Date 01/13/2014
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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