The following data is part of a premarket notification filed by Chiron Vision Corp. with the FDA for Passport Foldable Lens Placement System.
| Device ID | K951292 |
| 510k Number | K951292 |
| Device Name: | PASSPORT FOLDABLE LENS PLACEMENT SYSTEM |
| Classification | Lens, Guide, Intraocular |
| Applicant | CHIRON VISION CORP. INDUST PARK HATO RTE 183 San Lorenzo, PR 00754 |
| Contact | Judy F Gordon |
| Correspondent | Judy F Gordon CHIRON VISION CORP. INDUST PARK HATO RTE 183 San Lorenzo, PR 00754 |
| Product Code | KYB |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-22 |
| Decision Date | 1995-06-02 |