The following data is part of a premarket notification filed by Bio-medical Sciences, Inc. with the FDA for Silon Topomat Corneal Topography Image Enhancement Device.
| Device ID | K981665 |
| 510k Number | K981665 |
| Device Name: | SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE |
| Classification | Topographer, Corneal, Ac-powered |
| Applicant | BIO-MEDICAL SCIENCES, INC. 101 TECHNOLOGY DR. Bethlehem, PA 18015 |
| Contact | Mark E Dillon |
| Correspondent | Mark E Dillon BIO-MEDICAL SCIENCES, INC. 101 TECHNOLOGY DR. Bethlehem, PA 18015 |
| Product Code | MMQ |
| CFR Regulation Number | 886.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-11 |
| Decision Date | 1998-12-07 |
| Summary: | summary |