The following data is part of a premarket notification filed by Delta Medical Industries with the FDA for Accu-rynge Pump Sp-250.
| Device ID | K830389 |
| 510k Number | K830389 |
| Device Name: | ACCU-RYNGE PUMP SP-250 |
| Classification | Pump, Infusion |
| Applicant | DELTA MEDICAL INDUSTRIES 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-10 |
| Decision Date | 1983-09-12 |