The following data is part of a premarket notification filed by Alcon Laboratories with the FDA for Alcon Series 20000 Legacy Phacoemulsifier.
Device ID | K952213 |
510k Number | K952213 |
Device Name: | ALCON SERIES 20000 LEGACY PHACOEMULSIFIER |
Classification | Unit, Phacofragmentation |
Applicant | ALCON LABORATORIES P.O. BOX 289 4218 HOWARD AVE. Kensington, MD 20795 |
Contact | David Krapf |
Correspondent | David Krapf ALCON LABORATORIES P.O. BOX 289 4218 HOWARD AVE. Kensington, MD 20795 |
Product Code | HQC |
CFR Regulation Number | 886.4670 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-11 |
Decision Date | 1995-08-09 |