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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 K163092
Device Name TubeClear Control Box and Clearing Stem
Applicant
Actuated Medical, Inc.
310 Rolling Ridge Drive
Bellefonte,  PA  16801
Applicant Contact Thomas L. Cronin
Correspondent
THIRD PARTY REVIEW GROUP, LLC
25 Independence Blvd
Warren,  NJ  07059
Correspondent Contact DAVE YUNGVIRT
Regulation Number876.5980
Classification Product Code
KNT  
Date Received11/04/2016
Decision Date 11/30/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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