The following data is part of a premarket notification filed by Optical Polymer Research, Inc. with the FDA for O-perm 30 A Rigid Gas Permeable Contact Lens.
| Device ID | K954124 |
| 510k Number | K954124 |
| Device Name: | O-PERM 30 A RIGID GAS PERMEABLE CONTACT LENS |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | OPTICAL POLYMER RESEARCH, INC. 235 NORTH TALBOT CT. Roswell, GA 30076 -2480 |
| Contact | Wally Stirling |
| Correspondent | Wally Stirling OPTICAL POLYMER RESEARCH, INC. 235 NORTH TALBOT CT. Roswell, GA 30076 -2480 |
| Product Code | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-01 |
| Decision Date | 1996-03-19 |
| Summary: | summary |