The following data is part of a premarket notification filed by Actuated Medical, Inc. with the FDA for Tubeclear System.
| Device ID | K200646 |
| 510k Number | K200646 |
| 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 | Douglas R. Dillon 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 | 2020-03-12 |
| Decision Date | 2020-12-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850458007003 | K200646 | 000 |