The following data is part of a premarket notification filed by Hospitec, Inc. with the FDA for Hospitec Medi-butler.
| Device ID | K954500 |
| 510k Number | K954500 |
| Device Name: | HOSPITEC MEDI-BUTLER |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | HOSPITEC, INC. 635 PRIOR AVE. NORTH Saint Paul, MN 55104 |
| Contact | Nic Orr |
| Correspondent | Nic Orr HOSPITEC, INC. 635 PRIOR AVE. NORTH Saint Paul, MN 55104 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-28 |
| Decision Date | 1996-01-18 |