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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oximeter, reprocessed
510(k) Number K101280
Device Name MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE
Applicant
MIDWEST REPROCESSING CENTER LLC
434 INDUSTRIAL LANE
BIRMINGHAM,  AL  35211
Applicant Contact JEROME JAMES
Correspondent
MIDWEST REPROCESSING CENTER LLC
434 INDUSTRIAL LANE
BIRMINGHAM,  AL  35211
Correspondent Contact JEROME JAMES
Regulation Number870.2700
Classification Product Code
NLF  
Date Received05/06/2010
Decision Date 10/07/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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