The following data is part of a premarket notification filed by Delta Medical Industries with the FDA for Accu-rynge Insulin Pump #sp-250.
Device ID | K820482 |
510k Number | K820482 |
Device Name: | ACCU-RYNGE INSULIN PUMP #SP-250 |
Classification | Pump, Infusion |
Applicant | DELTA MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-02-22 |
Decision Date | 1982-03-26 |