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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K970344
Device Name MDILOG, MODEL MDC-511
Applicant
MEDTRAK TECHNOLOGIES, INC.
12364 W. ALAMEDA PKWY.
SUITE 115
LAKEWOOD,  CO  80228
Applicant Contact LINDA NELSON
Correspondent
MEDTRAK TECHNOLOGIES, INC.
12364 W. ALAMEDA PKWY.
SUITE 115
LAKEWOOD,  CO  80228
Correspondent Contact LINDA NELSON
Regulation Number868.5630
Classification Product Code
CAF  
Date Received01/29/1997
Decision Date 08/06/1997
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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