The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Corneal Transplant Trephine Disposable Blade.
| Device ID | K861825 |
| 510k Number | K861825 |
| Device Name: | CORNEAL TRANSPLANT TREPHINE DISPOSABLE BLADE |
| Classification | Trephine, Manual, Ophthalmic |
| Applicant | STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Contact | Cindy Pestka |
| Correspondent | Cindy Pestka STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Product Code | HRH |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-12 |
| Decision Date | 1986-06-09 |