The following data is part of a premarket notification filed by Incutech, Inc. with the FDA for Solution Transfer Container W/attached Leg Set (empty).
| Device ID | K940258 |
| 510k Number | K940258 |
| Device Name: | SOLUTION TRANSFER CONTAINER W/ATTACHED LEG SET (EMPTY) |
| 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 | 1994-01-21 |
| Decision Date | 1994-03-28 |