The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Storz M824 Fixation Device For Retractive Surgery.
| Device ID | K931731 |
| 510k Number | K931731 |
| Device Name: | STORZ M824 FIXATION DEVICE FOR RETRACTIVE SURGERY |
| Classification | Device, Fixation, Ac-powered, Ophthalmic |
| Applicant | STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Contact | Michael T Taggart |
| Correspondent | Michael T Taggart STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Product Code | HPL |
| CFR Regulation Number | 886.1290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-07 |
| Decision Date | 1994-08-29 |