The following data is part of a premarket notification filed by Polamedco, Inc. with the FDA for Omnisurg Side Mounting Clamp & Rail Ext..
| Device ID | K821933 |
| 510k Number | K821933 |
| Device Name: | OMNISURG SIDE MOUNTING CLAMP & RAIL EXT. |
| Classification | Operating Room Accessories Table Tray |
| Applicant | POLAMEDCO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FWZ |
| CFR Regulation Number | 878.4950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-29 |
| Decision Date | 1982-07-08 |