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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 K122379
Device Name FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 19MM X 135CM
Applicant
OSTIAL CORPORATION
510 clyde avenue
mountain view,  CA  94043
Applicant Contact kaitlin von hoffmann
Correspondent
OSTIAL CORPORATION
510 clyde avenue
mountain view,  CA  94043
Correspondent Contact kaitlin von hoffmann
Regulation Number870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received08/06/2012
Decision Date 09/05/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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