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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reprocessed Atherectomy Catheter
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
Applicant Contact Matthew Farley
Correspondent
Northeast Scientific, Inc.
2142 Thomaston Ave.
Waterbury,  CT  06704
Correspondent Contact Matthew Farley
Regulation Number870.4875
Classification Product Code
QTF  
Date Received01/21/2022
Decision Date 07/01/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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