The following data is part of a premarket notification filed by Volu Sol Medical Industries with the FDA for Volu-sol Gills Ea.
Device ID | K822035 |
510k Number | K822035 |
Device Name: | VOLU-SOL GILLS EA |
Classification | Stain, Papanicolau |
Applicant | VOLU SOL MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HZJ |
CFR Regulation Number | 864.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-07-12 |
Decision Date | 1982-08-03 |