The following data is part of a premarket notification filed by Surgi-quip Inc.u with the FDA for Electronic Unit.
Device ID | K832887 |
510k Number | K832887 |
Device Name: | ELECTRONIC UNIT |
Classification | Microscope, Surgical |
Applicant | SURGI-QUIP INC.U 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EPT |
CFR Regulation Number | 878.4700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-08-26 |
Decision Date | 1983-10-04 |