The following data is part of a premarket notification filed by Storz with the FDA for Storz Micro Cutter 25 Gauge Pack.
| Device ID | K913504 |
| 510k Number | K913504 |
| Device Name: | STORZ MICRO CUTTER 25 GAUGE PACK |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | STORZ 3365 TREE COURT INDUSTRIAL BOULEVARD St. Louis, MO 63122 |
| Contact | Michael T Taggart |
| Correspondent | Michael T Taggart STORZ 3365 TREE COURT INDUSTRIAL BOULEVARD St. Louis, MO 63122 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-07 |
| Decision Date | 1992-02-21 |