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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K120931
Device Name CRITICAL CARE VENTILATOR
Applicant
Oricare, Inc.
1900 Am Dr.,
Quakertow.,  PA  18951
Applicant Contact DAVID JAMISON
Correspondent
Oricare, Inc.
1900 Am Dr.,
Quakertow.,  PA  18951
Correspondent Contact DAVID JAMISON
Regulation Number868.5895
Classification Product Code
CBK  
Subsequent Product Codes
BTI   BTT   CCK  
Date Received03/27/2012
Decision Date 06/06/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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