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FDA 510(k) Application Details - K200205
Device Classification Name
Catheter, Recording, Electrode, Reprocessed
More FDA Info for this Device
510(K) Number
K200205
Device Name
Catheter, Recording, Electrode, Reprocessed
Applicant
Stryker Sustainability Solutions
1810 W Drake Drive
Tempe, AZ 85283 US
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Contact
Mia McCorkel
Other 510(k) Applications for this Contact
Regulation Number
870.1220
More FDA Info for this Regulation Number
Classification Product Code
NLH
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More FDA Info for this Product Code
Date Received
01/28/2020
Decision Date
05/13/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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