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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 K121571
Model MODEL 101
Device Name TUBECLEAR
Applicant
ACTUATED MEDICAL, INC
310 rolling ridge dr
bellefonte,  PA  16823
Contact debora demers
Regulation Number876.5980
Classification Product Code
KNT  
Date Received05/29/2012
Decision Date 06/13/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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