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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name conserver, oxygen
510(k) Number K131023
Device Name THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN
Applicant
MEDICAL PRODUCTS, LLC
7437 OAKLANDON RD.
INDIANAPOLIS,  IN  46236
Applicant Contact DAVID MCGILL
Correspondent
MEDICAL PRODUCTS, LLC
7437 OAKLANDON RD.
INDIANAPOLIS,  IN  46236
Correspondent Contact DAVID MCGILL
Regulation Number868.5905
Classification Product Code
NFB  
Date Received04/12/2013
Decision Date 10/11/2013
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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