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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 K990185
Device Name MDILOG, MODEL MDC-512
Applicant
MEDTRAK TECHNOLOGIES, INC.
6950 WEST JEFFERSON AVE., #210
LAKEWOOD,  CO  80235
Applicant Contact LINDA L NELSON
Correspondent
MEDTRAK TECHNOLOGIES, INC.
6950 WEST JEFFERSON AVE., #210
LAKEWOOD,  CO  80235
Correspondent Contact LINDA L NELSON
Regulation Number868.5630
Classification Product Code
CAF  
Date Received01/20/1999
Decision Date 04/01/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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