The following data is part of a premarket notification filed by Gilmore Liquid Air Co. with the FDA for Gcs-79.
Device ID | K801921 |
510k Number | K801921 |
Device Name: | GCS-79 |
Classification | Unit, Cryosurgical, Accessories |
Applicant | GILMORE LIQUID AIR CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GEH |
CFR Regulation Number | 878.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-08-05 |
Decision Date | 1980-10-31 |