FDA 510(k) Application Details - K201699

Device Classification Name Oximeter, Reprocessed

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510(K) Number K201699
Device Name Oximeter, Reprocessed
Applicant Surgical Instrument and Savings Inc (dba Medline ReNewal)
1500 NE Hemlock Ave
Redmond, OR 97756 US
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Contact Stephanie Boyle Mays
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Regulation Number 870.2700

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Classification Product Code NLF
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Date Received 06/22/2020
Decision Date 07/22/2020
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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