The following data is part of a premarket notification filed by Coburn Optical Ind., Inc. with the FDA for Irrigation & Aspiration/vitrectomy Device.
| Device ID | K862188 |
| 510k Number | K862188 |
| Device Name: | IRRIGATION & ASPIRATION/VITRECTOMY DEVICE |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | COBURN OPTICAL IND., INC. 1365 HAMLET AVE. P.O. BOX 2498 Clearwater, FL 33516 |
| Contact | Annette M Hillring |
| Correspondent | Annette M Hillring 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 | 1986-06-09 |
| Decision Date | 1986-08-21 |