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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 K051629
Device Name BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000
Applicant
BLEASE USA, INC.
962 ALLEGRO LANE
APOLLO BEACH,  FL  33572
Applicant Contact ARTHUR J WARD
Correspondent
BLEASE USA, INC.
962 ALLEGRO LANE
APOLLO BEACH,  FL  33572
Correspondent Contact ARTHUR J WARD
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received06/20/2005
Decision Date 09/23/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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