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 |