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510(k) K123659

TUBE-CLEAR, CONTROL BOX (COMPONENT OF TUBECLEAR), CLEARING STEM (COMPONENT OF TUBECLEAR) by Actuated Medical, Inc. — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2012
Date Received
November 28, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Gastrointestinal (And Accessories)
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

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  • K131052 — TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS) (August 16, 2013)
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  • K241185 — CORGRIP* SR NG/NI Tube Retention System (October 25, 2024)
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