The following data is part of a premarket notification filed by Flexmedics with the FDA for Flexmedics Malleable Cannula.
| Device ID | K910674 |
| 510k Number | K910674 |
| Device Name: | FLEXMEDICS MALLEABLE CANNULA |
| Classification | Arthroscope |
| Applicant | FLEXMEDICS 620 FORD CTR., 420 N. FIFTH STREET Minneapolis, MN 55401 |
| Contact | Timothy Ley |
| Correspondent | Timothy Ley FLEXMEDICS 620 FORD CTR., 420 N. FIFTH STREET Minneapolis, MN 55401 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-15 |
| Decision Date | 1991-04-12 |