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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 K003052
Device Name NUMED TYSHAK II AND Z-MED II PTV CATHETERS
Applicant
NuMED, Inc.
P.O Box 129
Nicholville,  NY  12965
Applicant Contact NICHELLE R LAFLESH
Correspondent
NuMED, Inc.
P.O Box 129
Nicholville,  NY  12965
Correspondent Contact NICHELLE R LAFLESH
Regulation Number870.1250
Classification Product Code
LIT  
Date Received10/02/2000
Decision Date 11/01/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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