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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(k) Number K061240
Device Name SHERLOCK TIP LOCATION SYSTEM (TLS) DETECTOR AND ACCESSORIES
Applicant
Lucent Medical Systems
811 Kirkland Ave.; Suite 100
Kirkland,  WA  98033
Applicant Contact CYNTHIA PESTKA
Correspondent
Lucent Medical Systems
811 Kirkland Ave.; Suite 100
Kirkland,  WA  98033
Correspondent Contact CYNTHIA PESTKA
Regulation Number880.5970
Classification Product Code
LJS  
Date Received05/03/2006
Decision Date 06/02/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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