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FDA 510(k) Application Details - K191018
Device Classification Name
Oximeter, Reprocessed
More FDA Info for this Device
510(K) Number
K191018
Device Name
Oximeter, Reprocessed
Applicant
Surgical Instrument Service and Savings Inc
(dba Medline ReNewal)
1500 NE Hemlock Ave.
Redmond, OR 97756 US
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Contact
Stephanie Boyle Mays
Other 510(k) Applications for this Contact
Regulation Number
870.2700
More FDA Info for this Regulation Number
Classification Product Code
NLF
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More FDA Info for this Product Code
Date Received
04/17/2019
Decision Date
07/03/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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