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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vaporizer, Anesthesia, Non-Heated
510(k) Number K942799
Device Name DATUM
Applicant
BLEASE USA, INC.
P.O. BOX 1395
LYNNWOOD,  WA  98036
Applicant Contact RICHARD KIRSCHNER
Correspondent
BLEASE USA, INC.
P.O. BOX 1395
LYNNWOOD,  WA  98036
Correspondent Contact RICHARD KIRSCHNER
Regulation Number868.5880
Classification Product Code
CAD  
Date Received06/15/1994
Decision Date 04/13/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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