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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 K040892
Device Name MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905
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 Received04/06/2004
Decision Date 04/29/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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