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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K062192
Device Name OSTIAL PRO STENT POSITIONING SYSTEM
Applicant
OSTIAL SOLUTIONS, LLC
155 MOFFETT PARK DRIVE
SUITE A-101
SUNNYVALE,  CA  94089
Applicant Contact MICHAEL J BILLIG
Correspondent
OSTIAL SOLUTIONS, LLC
155 MOFFETT PARK DRIVE
SUITE A-101
SUNNYVALE,  CA  94089
Correspondent Contact MICHAEL J BILLIG
Regulation Number870.1330
Classification Product Code
DQX  
Date Received07/31/2006
Decision Date 05/24/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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