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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aspiration Thrombectomy Catheter
510(k) Number K071826
Device Name THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910
Applicant
Fox Hollow Technologies
740 Bay Rd.
Redwood City,  CA  94063
Applicant Contact SRIDEVI SHESHADRI
Correspondent
Fox Hollow Technologies
740 Bay Rd.
Redwood City,  CA  94063
Correspondent Contact SRIDEVI SHESHADRI
Regulation Number870.5150
Classification Product Code
QEZ  
Subsequent Product Code
KRA  
Date Received07/03/2007
Decision Date 11/09/2007
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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