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FDA 510(k) Application Details - K200195
Device Classification Name
Catheter, Ultrasound, Intravascular
More FDA Info for this Device
510(K) Number
K200195
Device Name
Catheter, Ultrasound, Intravascular
Applicant
Northeast Scientific, Inc.
2142 Thomaston Ave.
Waterbury, CT 06704 US
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Contact
Matthew Farley
Other 510(k) Applications for this Contact
Regulation Number
870.1200
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Classification Product Code
OBJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/27/2020
Decision Date
06/22/2020
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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