The following data is part of a premarket notification filed by Volk Optical, Inc. with the FDA for Quadraspheric Fundus Lens.
| Device ID | K943125 |
| 510k Number | K943125 |
| Device Name: | QUADRASPHERIC FUNDUS LENS |
| Classification | Lens, Contact, Polymethylmethacrylate, Diagnostic |
| Applicant | VOLK OPTICAL, INC. BOND COURT BUILDING 1300 EAST NINTH ST., STE 900 Cleveland, OH 44114 |
| Contact | James A Goldsmith |
| Correspondent | James A Goldsmith VOLK OPTICAL, INC. BOND COURT BUILDING 1300 EAST NINTH ST., STE 900 Cleveland, OH 44114 |
| Product Code | HJK |
| CFR Regulation Number | 886.1385 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-29 |
| Decision Date | 1994-09-02 |