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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
510(k) Number K003276
Device Name TYSHAK MINI PEDIATRIC PTV CATHETER, MODEL 107
Applicant
NuMED, Inc.
2880 Main St.
Hopkinton,  NY  12965
Applicant Contact NICHELLE R LAFLESH
Correspondent
NuMED, Inc.
2880 Main St.
Hopkinton,  NY  12965
Correspondent Contact NICHELLE R LAFLESH
Regulation Number870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received10/19/2000
Decision Date 12/01/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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