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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheters, transluminal coronary angioplasty, percutaneous
510(k) Number K111284
Device Name FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM
Applicant
OSTIAL CORPORATION
510 CLYDE AVENUE
MOUNTAIN VIEW,  CA  94043
Applicant Contact Mark Smutka
Correspondent
OSTIAL CORPORATION
510 CLYDE AVENUE
MOUNTAIN VIEW,  CA  94043
Correspondent Contact Mark Smutka
Regulation Number870.5100
Classification Product Code
LOX  
Date Received05/06/2011
Decision Date 08/17/2011
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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