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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Irrigation, Ocular Surgery
510(k) Number K881682
Device Name ALCON SITE(R)-COMPATIBLE CASSETTE
Applicant
Alcon Laboratories
6201 S. Fwy.
P.O. Box 6600
Fort Worth,  TX  76134
Applicant Contact REBECCA G WALKERS
Correspondent
Alcon Laboratories
6201 S. Fwy.
P.O. Box 6600
Fort Worth,  TX  76134
Correspondent Contact REBECCA G WALKERS
Regulation Number886.4360
Classification Product Code
KYG  
Date Received04/19/1988
Decision Date 07/01/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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