The following data is part of a premarket notification filed by Matrix Medica, Inc. with the FDA for Matrix Dri-idea (plastic Dispos. Surgical Gown).
| Device ID | K850177 |
| 510k Number | K850177 |
| Device Name: | MATRIX DRI-IDEA (PLASTIC DISPOS. SURGICAL GOWN) |
| Classification | Gown, Surgical |
| Applicant | MATRIX MEDICA, INC. 1089 AIRPORT RD. Minden, NV 89423 |
| Contact | Charles C Lincoln |
| Correspondent | Charles C Lincoln MATRIX MEDICA, INC. 1089 AIRPORT RD. Minden, NV 89423 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-17 |
| Decision Date | 1985-02-21 |