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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Phacofragmentation
510(k) Number K843386
Device Name MENDEZ U/S CYSTOTOME
Applicant
CooperVision, Inc.
P.O. Box 19587
Irvine,  CA  92713
Applicant Contact DOUGLAS G ALLEN
Correspondent
CooperVision, Inc.
P.O. Box 19587
Irvine,  CA  92713
Correspondent Contact DOUGLAS G ALLEN
Regulation Number886.4670
Classification Product Code
HQC  
Date Received08/28/1984
Decision Date 11/27/1984
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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