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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 K200646
Device Name TubeClear System
Applicant
Actuated Medical, Inc.
310 Rolling Ridge Dr.
Bellefonte,  PA  16823
Applicant Contact Michael T. Britton
Correspondent
Actuated Medical, Inc.
310 Rolling Ridge Dr.
Bellefonte,  PA  16823
Correspondent Contact Douglas R. Dillon
Regulation Number876.5980
Classification Product Code
KNT  
Date Received03/12/2020
Decision Date 12/04/2020
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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