The following data is part of a premarket notification filed by Coburn Optical Ind., Inc. with the FDA for Meditec (rodenstock) Laser Photocoagul.
| Device ID | K791659 |
| 510k Number | K791659 |
| Device Name: | MEDITEC (RODENSTOCK) LASER PHOTOCOAGUL |
| Classification | Laser, Ophthalmic |
| Applicant | COBURN OPTICAL IND., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-08-22 |
| Decision Date | 1979-10-11 |