The following data is part of a premarket notification filed by Infinity Surgical Technology, Inc. with the FDA for Infinity Micro Irrigator.
| Device ID | K924052 |
| 510k Number | K924052 |
| Device Name: | INFINITY MICRO IRRIGATOR |
| Classification | Device, Irrigation, Ocular Surgery |
| Applicant | INFINITY SURGICAL TECHNOLOGY, INC. 3174 DOOLITTLE DR. Northbrook, IL 60062 |
| Contact | Bernhard Teitz |
| Correspondent | Bernhard Teitz INFINITY SURGICAL TECHNOLOGY, INC. 3174 DOOLITTLE DR. Northbrook, IL 60062 |
| Product Code | KYG |
| CFR Regulation Number | 886.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-12 |
| Decision Date | 1992-12-23 |