The following data is part of a premarket notification filed by Actuated Medical, Inc with the FDA for Tubeclear.
| Device ID | K121571 |
| 510k Number | K121571 |
| Device Name: | TUBECLEAR |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | ACTUATED MEDICAL, INC 310 ROLLING RIDGE DR Bellefonte, PA 16823 |
| Contact | Debora Demers |
| Correspondent | William Sammons INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-05-29 |
| Decision Date | 2012-06-13 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() TUBECLEAR 86383919 4731056 Live/Registered |
Actuated Medical, Inc. 2014-09-03 |
![]() TUBECLEAR 85662925 4373836 Live/Registered |
Actuated Medical, Inc. 2012-06-27 |