The following data is part of a premarket notification filed by Actuated Medical, Inc. with the FDA for Tubeclear Model 101 (with New Clearing Stem Ne And G Models).
| Device ID | K131052 |
| 510k Number | K131052 |
| Device Name: | TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS) |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | ACTUATED MEDICAL, INC. 310 ROLLING RIDGE DR Bellefonte, PA 16823 |
| Contact | Debora Demers, Ph.d. |
| Correspondent | Jeff D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-04-15 |
| Decision Date | 2013-08-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20850458007557 | K131052 | 000 |
| 20850458007083 | K131052 | 000 |
| 20850458007090 | K131052 | 000 |
| 20850458007106 | K131052 | 000 |
| 20850458007113 | K131052 | 000 |
| 20850458007120 | K131052 | 000 |
| 20850458007144 | K131052 | 000 |
| 00850458007362 | K131052 | 000 |
| 20850458007427 | K131052 | 000 |
| 20850458007434 | K131052 | 000 |
| 20850458007458 | K131052 | 000 |
| 20850458007489 | K131052 | 000 |
| 20850458007502 | K131052 | 000 |
| 00850458007010 | K131052 | 000 |