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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular Occluding, Temporary
510(k) Number K131869
Device Name PTS-X SIZING BALLOON CATHETER
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 Number870.4450
Classification Product Code
MJN  
Date Received06/24/2013
Decision Date 08/08/2013
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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