The following data is part of a premarket notification filed by Medsurg Industries, Inc. with the FDA for Medsurg O.r. Procedure Tray.
| Device ID | K914037 |
| 510k Number | K914037 |
| Device Name: | MEDSURG O.R. PROCEDURE TRAY |
| Classification | General Surgery Tray |
| Applicant | MEDSURG INDUSTRIES, INC. 251 EXCHANGE PLACE Herndon, VA 20170 -4822 |
| Contact | Thomas Bonner |
| Correspondent | Thomas Bonner MEDSURG INDUSTRIES, INC. 251 EXCHANGE PLACE Herndon, VA 20170 -4822 |
| Product Code | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-10 |
| Decision Date | 1993-06-22 |