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FDA 510(k) Application Details - K201518
Device Classification Name
More FDA Info for this Device
510(K) Number
K201518
Device Name
Route 92 Medical 088 Access System
Applicant
Route 92 Medical
155 Bovet Road, Suite 100
San Mateo, CA 94402 US
Other 510(k) Applications for this Company
Contact
Kathy Tansey
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QJP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/08/2020
Decision Date
08/14/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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