The following data is part of a premarket notification filed by Infinitech, Inc. with the FDA for Infinitech High Intensity Xenon Light Source System.
| Device ID | K951627 |
| 510k Number | K951627 |
| Device Name: | INFINITECH HIGH INTENSITY XENON LIGHT SOURCE SYSTEM |
| Classification | Endoilluminator |
| 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 | MPA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-07 |
| Decision Date | 1995-10-19 |