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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 K991977
Device Name TYSHAK, MODEL 102 AND Z-MED, MODEL 302
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
LIT  
Date Received06/11/1999
Decision Date 09/27/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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