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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 K931009
Device Name TYSHAK PERIPHERAL BALLOON DILATION CATHETER
Applicant
NUMED, INC.
MAIN ST.
HOPKINTON,  NY  12940
Applicant Contact SUSAN D JONES
Correspondent
NUMED, INC.
MAIN ST.
HOPKINTON,  NY  12940
Correspondent Contact SUSAN D JONES
Regulation Number870.1250
Classification Product Code
LIT  
Date Received02/19/1993
Decision Date 12/21/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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