The following data is part of a premarket notification filed by Incutech, Inc. with the FDA for Empty, Solution Transfer Container With Detatchable Leg Set.
| Device ID | K941731 |
| 510k Number | K941731 |
| Device Name: | EMPTY, SOLUTION TRANSFER CONTAINER WITH DETATCHABLE LEG SET |
| Classification | Container, I.v. |
| Applicant | INCUTECH, INC. 307-A SOUTH WESTGATE DR. Greensboro, NC 27407 |
| Contact | Roger V Molina |
| Correspondent | Roger V Molina INCUTECH, INC. 307-A SOUTH WESTGATE DR. Greensboro, NC 27407 |
| Product Code | KPE |
| CFR Regulation Number | 880.5025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-07 |
| Decision Date | 1994-07-22 |