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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K051559
Device Name IMASK, MODELS 100, 200 AND 300
Applicant
VITAL SIGNS COLORADO, INC.
11039 EAST LANSING CIR.
ENGLEWOOD,  CO  80112
Applicant Contact TOM DIELMANN
Correspondent
VITAL SIGNS COLORADO, INC.
11039 EAST LANSING CIR.
ENGLEWOOD,  CO  80112
Correspondent Contact TOM DIELMANN
Regulation Number868.5905
Classification Product Code
BZD  
Date Received06/13/2005
Decision Date 07/08/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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