The following data is part of a premarket notification filed by Delta Medical Industries with the FDA for Delivery Tube Set #2226.
Device ID | K822761 |
510k Number | K822761 |
Device Name: | DELIVERY TUBE SET #2226 |
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 | 1982-09-14 |
Decision Date | 1982-09-30 |