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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 W. Jefferson Ave., #210
Lakewood,  CO  80235
Applicant Contact LINDA L NELSON
Correspondent
Medtrak Technologies, Inc.
6950 W. 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
Predetermined Change
Control Plan Authorized		 No
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