The following data is part of a premarket notification filed by Coburn Optical Ind., Inc. with the FDA for Coburn I/a System.
| Device ID | K853457 |
| 510k Number | K853457 |
| Device Name: | COBURN I/A SYSTEM |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | COBURN OPTICAL IND., INC. 1365 HAMLET AVE. P.O. BOX 2498 Clearwater, FL 33516 |
| Contact | James S Miller |
| Correspondent | James S Miller COBURN OPTICAL IND., INC. 1365 HAMLET AVE. P.O. BOX 2498 Clearwater, FL 33516 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-16 |
| Decision Date | 1985-10-15 |