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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 K982137
Device Name BLEASE FRONTLINE GENIUS RANGE ANAESTHESIA MACHINE
Applicant
Blease Medical Equipment , Ltd.
12601 Research Pkwy.
Att: Francis X Casey
Orlando,  FL  32826
Applicant Contact FRANCIS X CASEY
Correspondent
Blease Medical Equipment , Ltd.
12601 Research Pkwy.
Att: Francis X Casey
Orlando,  FL  32826
Correspondent Contact FRANCIS X CASEY
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received06/17/1998
Decision Date 04/09/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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