The following data is part of a premarket notification filed by Matrix Medica, Inc. with the FDA for Flexscope.
| Device ID | K961536 |
| 510k Number | K961536 |
| Device Name: | FLEXSCOPE |
| Classification | Endoscope, Fiber Optic |
| Applicant | MATRIX MEDICA, INC. 14055 GRAND AVE. SUITE D Burnsville, MN 55337 |
| Contact | Amjad Ahmad |
| Correspondent | Amjad Ahmad MATRIX MEDICA, INC. 14055 GRAND AVE. SUITE D Burnsville, MN 55337 |
| Product Code | GDB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-22 |
| Decision Date | 1996-09-18 |
| Summary: | summary |