The following data is part of a premarket notification filed by Pharmaseal Laboratories with the FDA for Fluid Dispensing System.
Device ID | K800362 |
510k Number | K800362 |
Device Name: | FLUID DISPENSING SYSTEM |
Classification | Dispenser, Liquid Medication |
Applicant | PHARMASEAL LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KYX |
CFR Regulation Number | 880.6430 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-02-20 |
Decision Date | 1980-03-12 |