The following data is part of a premarket notification filed by Optical Polymer Research, Inc. with the FDA for O-perm 30.
| Device ID | K002703 |
| 510k Number | K002703 |
| Device Name: | O-PERM 30 |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | OPTICAL POLYMER RESEARCH, INC. 5921 N.E. 38TH ST. Gainesville, FL 32609 |
| Contact | Werner P Schuman |
| Correspondent | Werner P Schuman OPTICAL POLYMER RESEARCH, INC. 5921 N.E. 38TH ST. Gainesville, FL 32609 |
| Product Code | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-30 |
| Decision Date | 2000-11-21 |