The following data is part of a premarket notification filed by Airperm, Inc. with the FDA for Airperm(siflufocon A) Rigid Gas Permeable Multifocal Contact Lenses For Daily Wear.
| Device ID | K962934 |
| 510k Number | K962934 |
| Device Name: | AIRPERM(SIFLUFOCON A) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENSES FOR DAILY WEAR |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | AIRPERM, INC. 4505 VAN NUYS BLVD. Sherman Oaks, CA 91403 |
| Contact | Nick Stoyan |
| Correspondent | Nick Stoyan AIRPERM, INC. 4505 VAN NUYS BLVD. Sherman Oaks, CA 91403 |
| Product Code | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-29 |
| Decision Date | 1996-08-27 |
| Summary: | summary |