The following data is part of a premarket notification filed by Quest Medical, Inc. with the FDA for Quest 521 Variable Pressure Volumetric Infusion Pu.
| Device ID | K851017 |
| 510k Number | K851017 |
| Device Name: | QUEST 521 VARIABLE PRESSURE VOLUMETRIC INFUSION PU |
| Classification | Pump, Infusion |
| Applicant | QUEST MEDICAL, INC. 3312 WILEY POST RD. Carrollton, TX 75006 |
| Contact | William A Franklin |
| Correspondent | William A Franklin QUEST MEDICAL, INC. 3312 WILEY POST RD. Carrollton, TX 75006 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-12 |
| Decision Date | 1985-05-07 |