The following data is part of a premarket notification filed by Alcon Laboratories with the FDA for Alcon Site(r)-compatible Cassette.
Device ID | K881682 |
510k Number | K881682 |
Device Name: | ALCON SITE(R)-COMPATIBLE CASSETTE |
Classification | Device, Irrigation, Ocular Surgery |
Applicant | ALCON LABORATORIES 6201 SOUTH FREEWAY PO BOX 6600 Fort Worth, TX 76134 -2099 |
Contact | Rebecca G Walkers |
Correspondent | Rebecca G Walkers ALCON LABORATORIES 6201 SOUTH FREEWAY PO BOX 6600 Fort Worth, TX 76134 -2099 |
Product Code | KYG |
CFR Regulation Number | 886.4360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-04-19 |
Decision Date | 1988-07-01 |