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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K181738
Device Name Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors
Applicant
Surgical Instrument Service and Savings Inc (dba Medline
ReNewal)
1500 NE Hemlock Ave.
Redmond,  OR  97756
Applicant Contact Stephanie Boyle Mays
Correspondent
Surgical Instrument Service and Savings Inc (dba Medline
ReNewal)
1500 NE Hemlock Ave.
Redmond,  OR  97756
Correspondent Contact Stephanie Boyle Mays
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
NLF  
Date Received07/02/2018
Decision Date 03/22/2019
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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