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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 K003972
Device Name NUMED GHOST II PTA CATHETERS
Applicant
NUMED, INC.
2880 MAIN ST.
HOPKINTON,  NY  12965
Applicant Contact NICHELL LAFLESH
Correspondent
NUMED, INC.
2880 MAIN ST.
HOPKINTON,  NY  12965
Correspondent Contact NICHELL LAFLESH
Regulation Number870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received12/22/2000
Decision Date 01/11/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
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