The following data is part of a premarket notification filed by Abbott Medical Optics Inc. with the FDA for Dual Pump Pack.
Device ID | K160236 |
510k Number | K160236 |
Device Name: | Dual Pump Pack |
Classification | Unit, Phacofragmentation |
Applicant | Abbott Medical Optics Inc. 1700 East Saint Andrew Place Santa Ana, CA 92705 |
Contact | Priya Viswanathan |
Correspondent | Priya Viswanathan Abbott Medical Optics Inc. 1700 East Saint Andrew Place 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 | 2016-02-01 |
Decision Date | 2016-04-27 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DUAL PUMP PACK 85779430 4544323 Live/Registered |
Dry Basement, Inc. 2012-11-14 |