The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Sterile/single Use Eye Sphere Implants.
| Device ID | K921106 |
| 510k Number | K921106 |
| Device Name: | STERILE/SINGLE USE EYE SPHERE IMPLANTS |
| Classification | Implant, Eye Sphere |
| Applicant | STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Contact | Janet Lacavich |
| Correspondent | Janet Lacavich STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Product Code | HPZ |
| CFR Regulation Number | 886.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-09 |
| Decision Date | 1992-03-30 |