The following data is part of a premarket notification filed by Actuated Medical, Inc. with the FDA for Tubeclear Control Box And Clearing Stem.
| Device ID | K163092 |
| 510k Number | K163092 |
| Device Name: | TubeClear Control Box And Clearing Stem |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | Actuated Medical, Inc. 310 Rolling Ridge Drive Bellefonte, PA 16801 |
| Contact | Thomas L. Cronin |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2016-11-04 |
| Decision Date | 2016-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20850458007625 | K163092 | 000 |
| 20850458007618 | K163092 | 000 |
| 20850458007601 | K163092 | 000 |