The following data is part of a premarket notification filed by Surgi-quip Inc.u with the FDA for Surgi-quip Microscope Stand.
Device ID | K822428 |
510k Number | K822428 |
Device Name: | SURGI-QUIP MICROSCOPE STAND |
Classification | Chair, Neurosurgical |
Applicant | SURGI-QUIP INC.U 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HBN |
CFR Regulation Number | 882.4125 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-08-12 |
Decision Date | 1982-09-02 |