TubeClear System

Tubes, Gastrointestinal (and Accessories)

Actuated Medical, Inc.

The following data is part of a premarket notification filed by Actuated Medical, Inc. with the FDA for Tubeclear System.

Pre-market Notification Details

Device IDK172556
510k NumberK172556
Device Name:TubeClear System
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant Actuated Medical, Inc. 310 Rolling Ridge Dr. Bellefonte,  PA  16823
ContactMichael T. Britton
CorrespondentMichael T. Britton
Actuated Medical, Inc. 310 Rolling Ridge Dr. Bellefonte,  PA  16823
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-08-24
Decision Date2018-06-29
Summary:summary

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