The following data is part of a premarket notification filed by Surgi-quip Inc.u with the FDA for Charles/mcintyre Giant Break Table.
| Device ID | K841115 |
| 510k Number | K841115 |
| Device Name: | CHARLES/MCINTYRE GIANT BREAK TABLE |
| Classification | Table, Operating-room, Ac-powered |
| Applicant | SURGI-QUIP INC.U 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FQO |
| CFR Regulation Number | 878.4960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-15 |
| Decision Date | 1984-05-09 |