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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 K093308
Device Name MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD
Applicant
Nidek Medical Products, Inc.
3949 Valley E. Industrial Dr.
Birmingham,  AL  35217
Applicant Contact JENNIFER MCWILLIAMS
Correspondent
Nidek Medical Products, Inc.
3949 Valley E. Industrial Dr.
Birmingham,  AL  35217
Correspondent Contact JENNIFER MCWILLIAMS
Regulation Number868.5440
Classification Product Code
CAW  
Date Received10/22/2009
Decision Date 01/14/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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