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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 K191018
Device Name Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive 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
NLF  
Subsequent Product Code
DQA  
Date Received04/17/2019
Decision Date 07/03/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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