The following data is part of a premarket notification filed by Acta Medical L.l.c. with the FDA for Enteral Administration Set With Solution Container, Enteral Administration Set, Enteral Extension Set With Minitube Conn.
| Device ID | K112863 |
| 510k Number | K112863 |
| Device Name: | ENTERAL ADMINISTRATION SET WITH SOLUTION CONTAINER, ENTERAL ADMINISTRATION SET, ENTERAL EXTENSION SET WITH MINITUBE CONN |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | ACTA MEDICAL L.L.C. 929 ARBOR DOWNS DRIVE Plano, TX 75023 |
| Contact | Aaron Compton |
| Correspondent | Aaron Compton ACTA MEDICAL L.L.C. 929 ARBOR DOWNS DRIVE Plano, TX 75023 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-30 |
| Decision Date | 2012-03-29 |
| Summary: | summary |