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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 K023683
Device Name MULTI-STRAP FULL FACE MASK
Applicant
ENGINEERED MEDICAL SYSTEMS
6329 W. WATERVIEW CT.
MCCORDSVILLE,  IN  46055
Applicant Contact PAUL DRYDEN
Correspondent
ENGINEERED MEDICAL SYSTEMS
6329 W. WATERVIEW CT.
MCCORDSVILLE,  IN  46055
Correspondent Contact PAUL DRYDEN
Regulation Number868.5905
Classification Product Code
BZD  
Date Received11/01/2002
Decision Date 12/01/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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