The following data is part of a premarket notification filed by Abbott Medical Optics Inc with the FDA for Laminar Flow Phaco Tips.
Device ID | K111882 |
510k Number | K111882 |
Device Name: | LAMINAR FLOW PHACO TIPS |
Classification | Unit, Phacofragmentation |
Applicant | ABBOTT MEDICAL OPTICS INC 1700 EAST SAINT ANDREW PL Santa Ana, CA 92705 |
Contact | Rosanne M Yetemian |
Correspondent | Rosanne M Yetemian ABBOTT MEDICAL OPTICS INC 1700 EAST SAINT ANDREW PL Santa Ana, CA 92705 |
Product Code | HQC |
CFR Regulation Number | 886.4670 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-07-01 |
Decision Date | 2011-11-07 |
Summary: | summary |