The following data is part of a premarket notification filed by Medsurg Industries, Inc. with the FDA for Medsurg Marshmallow Tray.
| Device ID | K920421 |
| 510k Number | K920421 |
| Device Name: | MEDSURG MARSHMALLOW TRAY |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| 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 | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-31 |
| Decision Date | 1993-12-13 |