The following data is part of a premarket notification filed by Metrix Co. with the FDA for Metricare Drug Reservoirs.
Device ID | K895924 |
510k Number | K895924 |
Device Name: | METRICARE DRUG RESERVOIRS |
Classification | Container, I.v. |
Applicant | METRIX CO. EVERGREEN PARK Dubuque, IA 52001 |
Contact | Donnelle Fuerste |
Correspondent | Donnelle Fuerste METRIX CO. EVERGREEN PARK Dubuque, IA 52001 |
Product Code | KPE |
CFR Regulation Number | 880.5025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-10-11 |
Decision Date | 1990-07-26 |