The following data is part of a premarket notification filed by Alcon Laboratories with the FDA for Cataract Liquefracture Device.
Device ID | K980292 |
510k Number | K980292 |
Device Name: | CATARACT LIQUEFRACTURE DEVICE |
Classification | Fluidic, Phacoemulsification/phacofragmentation |
Applicant | ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth, TX 76134 -2099 |
Contact | Martin A Kaufman |
Correspondent | Martin A Kaufman ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth, TX 76134 -2099 |
Product Code | MUS |
CFR Regulation Number | 886.4670 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-01-26 |
Decision Date | 1998-05-19 |
Summary: | summary |