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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 K001727
Device Name MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHINES
Applicant
BLEASE MEDICAL EQUIPMENT LTD.
962 ALLEGRO LN.
APOLLO BEACH,  FL  33572
Applicant Contact ART WARD
Correspondent
BLEASE MEDICAL EQUIPMENT LTD.
962 ALLEGRO LN.
APOLLO BEACH,  FL  33572
Correspondent Contact ART WARD
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received06/06/2000
Decision Date 08/09/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
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