The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Scleral Sponge Ii, Olk Design, E5395-10 & E5395-11.
| Device ID | K850883 |
| 510k Number | K850883 |
| Device Name: | SCLERAL SPONGE II, OLK DESIGN, E5395-10 & E5395-11 |
| Classification | Sponge, Ophthalmic |
| Applicant | STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Contact | Tom Grant |
| Correspondent | Tom Grant STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Product Code | HOZ |
| CFR Regulation Number | 886.4790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-04 |
| Decision Date | 1985-03-20 |