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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 K041309
Device Name IMASK TM
Applicant
Vital Signs, Inc.
11039 E. Lansing Circle
Englewood,  CO 
Applicant Contact THOMAS DIELMANN
Correspondent
Vital Signs, Inc.
11039 E. Lansing Circle
Englewood,  CO 
Correspondent Contact THOMAS DIELMANN
Regulation Number868.5905
Classification Product Code
BZD  
Date Received05/17/2004
Decision Date 06/30/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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