The following data is part of a premarket notification filed by Matrix Medica, Inc. with the FDA for Matrx, Pyramid Triangle Bandage.
| Device ID | K912661 |
| 510k Number | K912661 |
| Device Name: | MATRX, PYRAMID TRIANGLE BANDAGE |
| Classification | Sling, Arm |
| Applicant | MATRIX MEDICA, INC. 145 MID COUNTY DR. Orchard Park, NY |
| Contact | John M Wynne |
| Correspondent | John M Wynne MATRIX MEDICA, INC. 145 MID COUNTY DR. Orchard Park, NY |
| Product Code | ILI |
| CFR Regulation Number | 890.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-18 |
| Decision Date | 1991-08-21 |