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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K120781
Device Name CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH
Applicant
Fuji Systems Corp.
3250 Second Ave.
San Diego,  CA  92103
Applicant Contact PAUL MASON
Correspondent
Fuji Systems Corp.
3250 Second Ave.
San Diego,  CA  92103
Correspondent Contact PAUL MASON
Regulation Number870.1250
Classification Product Code
DQY  
Date Received03/15/2012
Decision Date 08/09/2012
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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