The following data is part of a premarket notification filed by Chiron Vision Corp. with the FDA for Mport Foldable Lens Placement System.
Device ID | K970727 |
510k Number | K970727 |
Device Name: | MPORT FOLDABLE LENS PLACEMENT SYSTEM |
Classification | Folders And Injectors, Intraocular Lens (iol) |
Applicant | CHIRON VISION CORP. 555 W. ARROW HWY. Claremont, CA 91711 |
Contact | Judy F Gordon |
Correspondent | Judy F Gordon CHIRON VISION CORP. 555 W. ARROW HWY. Claremont, CA 91711 |
Product Code | MSS |
CFR Regulation Number | 886.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-02-28 |
Decision Date | 1997-12-17 |
Summary: | summary |