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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon
510(k) Number K213915
Device Name BIB Stent Placement Catheter
Applicant
NuMED, Inc.
2880 Main St.
Hopkinton,  NY  12965
Applicant Contact Nichelle LaFlesh
Correspondent
NuMED, Inc.
2880 Main St.
Hopkinton,  NY  12965
Correspondent Contact Nichelle LaFlesh
Regulation Number870.1250
Classification Product Code
NVM  
Date Received12/15/2021
Decision Date 01/12/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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