The following data is part of a premarket notification filed by Repro-med Systems, Inc. with the FDA for Repro-med Systems Infusion Device.
| Device ID | K844401 |
| 510k Number | K844401 |
| Device Name: | REPRO-MED SYSTEMS INFUSION DEVICE |
| Classification | Pump, Infusion |
| Applicant | REPRO-MED SYSTEMS, INC. P.O. BOX 191 713 NORTH STREET Middletown, NY 10940 |
| Contact | Andrew I Sealfon |
| Correspondent | Andrew I Sealfon REPRO-MED SYSTEMS, INC. P.O. BOX 191 713 NORTH STREET Middletown, NY 10940 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-13 |
| Decision Date | 1985-03-12 |