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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas-Machine, Anesthesia
510(k) Number K131790
Device Name A9800 ANESTHESIA WORKSTATION
Applicant
Oricare, Inc.
1900 Am Dr.,
Quakertow.,  PA  18951
Applicant Contact KURTIS MONTEGNA
Correspondent
Oricare, Inc.
1900 Am Dr.,
Quakertow.,  PA  18951
Correspondent Contact KURTIS MONTEGNA
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received06/18/2013
Decision Date 05/09/2014
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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