The following data is part of a premarket notification filed by Imm Enterprises Ltd. with the FDA for Cat. 14-clinical Toxiology Devices.
Device ID | K840318 |
510k Number | K840318 |
Device Name: | CAT. 14-CLINICAL TOXIOLOGY DEVICES |
Classification | Forceps |
Applicant | IMM ENTERPRISES LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HTD |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-01-24 |
Decision Date | 1984-04-23 |