The following data is part of a premarket notification filed by Ocular Instruments, Inc. with the FDA for Woldoff Prismatic Biconcave Lens.
| Device ID | K894421 |
| 510k Number | K894421 |
| Device Name: | WOLDOFF PRISMATIC BICONCAVE LENS |
| Classification | Lens, Contact, Polymethylmethacrylate, Diagnostic |
| Applicant | OCULAR INSTRUMENTS, INC. 2255 116TH AVE., N.E. Bellevue, WA 98004 -3039 |
| Contact | J Erickson |
| Correspondent | J Erickson OCULAR INSTRUMENTS, INC. 2255 116TH AVE., N.E. Bellevue, WA 98004 -3039 |
| Product Code | HJK |
| CFR Regulation Number | 886.1385 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-17 |
| Decision Date | 1989-10-04 |