The following data is part of a premarket notification filed by Sterling Medical Devices, Inc. with the FDA for Uvp 2000 Volumed -tentative.
Device ID | K850997 |
510k Number | K850997 |
Device Name: | UVP 2000 VOLUMED -TENTATIVE |
Classification | Pump, Infusion |
Applicant | STERLING MEDICAL DEVICES, INC. 1616 WEST SHAW AVE. SUITE D-1 Fresno, CA 93711 |
Contact | Frank Ferguson |
Correspondent | Frank Ferguson STERLING MEDICAL DEVICES, INC. 1616 WEST SHAW AVE. SUITE D-1 Fresno, CA 93711 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-03-11 |
Decision Date | 1985-05-13 |