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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 K113769
Device Name GPSCATH BALLON DILATATION CATHETER
Applicant
Hotspur Technologies
880 Maude Ave., Suite A
Mountain View,  CA  94043
Applicant Contact Eric Ankerud
Correspondent
Hotspur Technologies
880 Maude Ave., Suite A
Mountain View,  CA  94043
Correspondent Contact Eric Ankerud
Regulation Number870.1250
Classification Product Code
LIT  
Date Received12/22/2011
Decision Date 01/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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