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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 K120285
Device Name K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER
Applicant
Curative Medical, Inc.
63 Chicory Ct.
Lake Jackson,  TX  77566
Applicant Contact AMY MCKINNEY
Correspondent
Curative Medical, Inc.
63 Chicory Ct.
Lake Jackson,  TX  77566
Correspondent Contact AMY MCKINNEY
Regulation Number868.5905
Classification Product Code
BZD  
Date Received01/31/2012
Decision Date 07/02/2012
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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