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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 K033973
Device Name OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR
Applicant
Nellcor Puritan Bennett, Inc.
4280 Hacienda Dr.
Pleasanton,  CA  94588
Applicant Contact LUANNE NG
Correspondent
Nellcor Puritan Bennett, Inc.
4280 Hacienda Dr.
Pleasanton,  CA  94588
Correspondent Contact LUANNE NG
Regulation Number870.2700
Classification Product Code
NLF  
Date Received12/22/2003
Decision Date 12/13/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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