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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Oxygen, Portable
510(k) Number K032509
Device Name MARK 5 NUVO (M5C5)
Applicant
NIDEK MEDICAL PRODUCTS, INC.
3949 VALLEY EAST INDUSTRIAL DR
BIRMINGHAM,  AL  35217
Applicant Contact JENNIFER MCWILLIAMS
Correspondent
NIDEK MEDICAL PRODUCTS, INC.
3949 VALLEY EAST INDUSTRIAL DR
BIRMINGHAM,  AL  35217
Correspondent Contact JENNIFER MCWILLIAMS
Regulation Number868.5440
Classification Product Code
CAW  
Date Received08/14/2003
Decision Date 03/18/2004
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
Recalls CDRH Recalls
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