The following data is part of a premarket notification filed by Coburn Optical Ind., Inc. with the FDA for Disp. Microsurgical Knives.
| Device ID | K821737 |
| 510k Number | K821737 |
| Device Name: | DISP. MICROSURGICAL KNIVES |
| Classification | Blade, Scalpel |
| Applicant | COBURN OPTICAL IND., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GES |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-14 |
| Decision Date | 1982-07-02 |