The following data is part of a premarket notification filed by Rand Scientific Corp. with the FDA for Trans-aire Rigid Gas Permable Contact Lens.
| Device ID | K955366 |
| 510k Number | K955366 |
| Device Name: | TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | RAND SCIENTIFIC CORP. 4135 NORTHGATE BLVD., SUITE 9 Sacramento, CA 95834 |
| Contact | Duane Tracy |
| Correspondent | Duane Tracy RAND SCIENTIFIC CORP. 4135 NORTHGATE BLVD., SUITE 9 Sacramento, CA 95834 |
| Product Code | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-22 |
| Decision Date | 1996-03-28 |