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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 K041430
Device Name BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000
Applicant
BLEASE MEDICAL EQUIPMENT LTD.
962 ALLEGRO LN.
APOLLO BEACH,  FL  33572
Applicant Contact ARTHUR J WARD
Correspondent
BLEASE MEDICAL EQUIPMENT LTD.
962 ALLEGRO LN.
APOLLO BEACH,  FL  33572
Correspondent Contact ARTHUR J WARD
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received05/28/2004
Decision Date 10/07/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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