The following data is part of a premarket notification filed by Infinitech, Inc. with the FDA for End-irrigating Endoilluminator.
| Device ID | K931546 |
| 510k Number | K931546 |
| Device Name: | END-IRRIGATING ENDOILLUMINATOR |
| Classification | Light, Surgical, Fiberoptic |
| Applicant | INFINITECH, INC. 750 GODDARD AVE. Chesterfield, MO 63005 |
| Contact | Alan T Beckman |
| Correspondent | Alan T Beckman INFINITECH, INC. 750 GODDARD AVE. Chesterfield, MO 63005 |
| Product Code | FST |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-29 |
| Decision Date | 1994-02-09 |