The following data is part of a premarket notification filed by Superior Plastic Products Corp. with the FDA for Enteral Nutrition Pump.
Device ID | K841630 |
510k Number | K841630 |
Device Name: | ENTERAL NUTRITION PUMP |
Classification | Pump, Infusion |
Applicant | SUPERIOR PLASTIC PRODUCTS CORP. 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 | 1984-04-19 |
Decision Date | 1984-06-07 |