The following data is part of a premarket notification filed by Norton Performance Plastics Corp. with the FDA for Fluid Administration Cat.#14-923.
Device ID | K790358 |
510k Number | K790358 |
Device Name: | FLUID ADMINISTRATION CAT.#14-923 |
Classification | Tubing, Noninvasive |
Applicant | NORTON PERFORMANCE PLASTICS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GAZ |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-02-13 |
Decision Date | 1979-03-21 |