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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 K123659
Device Name TUBE-CLEAR, CONTROL BOX (COMPONENT OF TUBECLEAR), CLEARING STEM (COMPONENT OF TUBECLEAR)
Applicant
ACTUATED MEDICAL, INC.
310 ROLLING RIDGE DR
BELLEFONTE,  PA  16823
Applicant Contact DEBORA DEMERS, PHD
Correspondent
ACTUATED MEDICAL, INC.
310 ROLLING RIDGE DR
BELLEFONTE,  PA  16823
Correspondent Contact DEBORA DEMERS, PHD
Regulation Number876.5980
Classification Product Code
KNT  
Date Received11/28/2012
Decision Date 12/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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