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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 K003251
Device Name BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690
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 Received10/17/2000
Decision Date 05/23/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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