The following data is part of a premarket notification filed by Infinitech, Inc. with the FDA for Infinitech Multi-spot Slit Lamp Laser Adapter.
| Device ID | K971950 |
| 510k Number | K971950 |
| Device Name: | INFINITECH MULTI-SPOT SLIT LAMP LASER ADAPTER |
| Classification | Laser, Ophthalmic |
| 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 | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-28 |
| Decision Date | 1997-08-01 |
| Summary: | summary |