The following data is part of a premarket notification filed by Acces Intl. Eyewear with the FDA for Titan Air Spectacle Frame.
| Device ID | K896350 |
| 510k Number | K896350 |
| Device Name: | TITAN AIR SPECTACLE FRAME |
| Classification | Implant, Absorbable, (scleral Buckling Methods) |
| Applicant | ACCES INTL. EYEWEAR 444 BUNKER RD. West Palm Beach, FL 33405 |
| Contact | Stephan Laudicino |
| Correspondent | Stephan Laudicino ACCES INTL. EYEWEAR 444 BUNKER RD. West Palm Beach, FL 33405 |
| Product Code | HQJ |
| CFR Regulation Number | 886.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-06 |
| Decision Date | 1989-12-18 |