The following data is part of a premarket notification filed by Frank Tanaka, Ocularist, Inc. with the FDA for Custom Ocular Prosthesis.
| Device ID | K946226 |
| 510k Number | K946226 |
| Device Name: | CUSTOM OCULAR PROSTHESIS |
| Classification | Eye, Artificial, Non-custom |
| Applicant | FRANK TANAKA, OCULARIST, INC. 3000 EAST FLETCHER AVE., SUITE 310 Tampa, FL 33613 |
| Contact | K F Tanaka |
| Correspondent | K F Tanaka FRANK TANAKA, OCULARIST, INC. 3000 EAST FLETCHER AVE., SUITE 310 Tampa, FL 33613 |
| Product Code | HQH |
| CFR Regulation Number | 886.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-22 |
| Decision Date | 1995-03-22 |