The following data is part of a premarket notification filed by Actuated Medical, Inc. with the FDA for Tube-clear, Control Box (component Of Tubeclear), Clearing Stem (component Of Tubeclear).
| Device ID | K123659 |
| 510k Number | K123659 |
| Device Name: | TUBE-CLEAR, CONTROL BOX (COMPONENT OF TUBECLEAR), CLEARING STEM (COMPONENT OF TUBECLEAR) |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | ACTUATED MEDICAL, INC. 310 ROLLING RIDGE DR Bellefonte, PA 16823 |
| Contact | Debora Demers, Phd |
| Correspondent | Debora Demers, Phd ACTUATED MEDICAL, INC. 310 ROLLING RIDGE DR Bellefonte, PA 16823 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-28 |
| Decision Date | 2012-12-20 |
| Summary: | summary |