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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Guide, Intraocular
510(k) Number K970033
Device Name MONARCH IOL DELIVERY SYSTEM
Applicant
Alcon Laboratories
6201 S. Fwy.
Fort Worth,  TX  76134
Applicant Contact MARTIN A KAUFMAN
Correspondent
Alcon Laboratories
6201 S. Fwy.
Fort Worth,  TX  76134
Correspondent Contact MARTIN A KAUFMAN
Regulation Number886.4300
Classification Product Code
KYB  
Date Received01/03/1997
Decision Date 04/23/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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