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FDA 510(k) Application Details - K220171
Device Classification Name
More FDA Info for this Device
510(K) Number
K220171
Device Name
NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter
Applicant
Northeast Scientific, Inc.
2142 Thomaston Ave.
Waterbury, CT 06704 US
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Contact
Matthew Farley
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Regulation Number
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Classification Product Code
QTF
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Date Received
01/21/2022
Decision Date
07/01/2022
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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