The following data is part of a premarket notification filed by Erika, Inc. with the FDA for National Med Care Infusion Pump Adm Set #95-0001-8.
| Device ID | K853134 |
| 510k Number | K853134 |
| Device Name: | NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8 |
| Classification | Pump, Infusion |
| Applicant | ERIKA, INC. ONE ERIKA PLAZA Rockleigh, NJ 07647 |
| Contact | Del Donna |
| Correspondent | Del Donna ERIKA, INC. ONE ERIKA PLAZA Rockleigh, NJ 07647 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-26 |
| Decision Date | 1985-11-06 |