The following data is part of a premarket notification filed by Airperm, Inc. with the FDA for Airperm (siflufocon A) Rigid Gas Permeable Ok Contact Lenses For Daily Wear Orthokeratology.
| Device ID | K973697 |
| 510k Number | K973697 |
| Device Name: | AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGY |
| Classification | Lens, Contact (orthokeratology) |
| 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 | MUW |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-26 |
| Decision Date | 1998-04-08 |
| Summary: | summary |