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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position
510(k) Number K093510
Device Name LUMENVU CATHETER GUIDANCE SYSTEM
Applicant
Sonosite,Inc.
1835 Market St., 29th Floor
Philedelphia,  PA  19103
Applicant Contact JANICE HOGAN
Correspondent
Sonosite,Inc.
1835 Market St., 29th Floor
Philedelphia,  PA  19103
Correspondent Contact JANICE HOGAN
Regulation Number880.5970
Classification Product Code
OMF  
Date Received11/12/2009
Decision Date 08/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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