The following data is part of a premarket notification filed by Pharmaceutical Infusion Technologies, Inc. with the FDA for Accupump 901 (model Numbers 50 & 100).
| Device ID | K953382 |
| 510k Number | K953382 |
| Device Name: | ACCUPUMP 901 (MODEL NUMBERS 50 & 100) |
| Classification | Pump, Infusion |
| Applicant | PHARMACEUTICAL INFUSION TECHNOLOGIES, INC. 6350 NAUTILUS DR. Boulder, CO 80301 |
| Contact | Charles C Duncan |
| Correspondent | Charles C Duncan PHARMACEUTICAL INFUSION TECHNOLOGIES, INC. 6350 NAUTILUS DR. Boulder, CO 80301 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-19 |
| Decision Date | 1995-10-17 |