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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 K890635
Device Name CAVITRON/KELMAN PHACOEMULSIFIER ASPIRATOR, UNIV.
Applicant
CooperVision, Inc.
17701 Cowan Ave.P. O. Box
19587
Irvine,  CA  92713
Applicant Contact DAVE KRAPF
Correspondent
CooperVision, Inc.
17701 Cowan Ave.P. O. Box
19587
Irvine,  CA  92713
Correspondent Contact DAVE KRAPF
Regulation Number886.4670
Classification Product Code
HQC  
Date Received02/08/1989
Decision Date 05/09/1989
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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