The following data is part of a premarket notification filed by Storz with the FDA for Storz Ophthalmic Bipolar Cautery Instruments (d8200, D8201, D8203) And Bipolar Cords (d8202, D8204).
| Device ID | K952151 |
| 510k Number | K952151 |
| Device Name: | STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204) |
| Classification | Apparatus, Cautery, Radiofrequency, Ac-powered |
| Applicant | STORZ 3365 TREE COURT INDUSTRIAL BOULEVARD St. Louis, MO 63122 |
| Contact | Audrey Swearingen |
| Correspondent | Audrey Swearingen STORZ 3365 TREE COURT INDUSTRIAL BOULEVARD St. Louis, MO 63122 |
| Product Code | HQR |
| CFR Regulation Number | 886.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-08 |
| Decision Date | 1996-03-04 |
| Summary: | summary |