The following data is part of a premarket notification filed by Actuated Medical, Inc. with the FDA for Tubeclear System.
Device ID | K172556 |
510k Number | K172556 |
Device Name: | TubeClear System |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | Actuated Medical, Inc. 310 Rolling Ridge Dr. Bellefonte, PA 16823 |
Contact | Michael T. Britton |
Correspondent | Michael T. Britton Actuated Medical, Inc. 310 Rolling Ridge Dr. Bellefonte, PA 16823 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-08-24 |
Decision Date | 2018-06-29 |
Summary: | summary |