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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K070449
Device Name LUMILOC (TM) SAFETY INTRODUCER NEEDLE
Applicant
Specialized Health Products International, Inc.
586 W. 500 S. #200
Salt Lake,  UT  84010
Applicant Contact Mark Nelson
Correspondent
Specialized Health Products International, Inc.
586 W. 500 S. #200
Salt Lake,  UT  84010
Correspondent Contact Mark Nelson
Regulation Number876.5980
Classification Product Code
KNT  
Date Received02/15/2007
Decision Date 06/14/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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