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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 K862063
Device Name ENTRAVISION MODECO II I/A MACHINE & I/A HANDPIECE
Applicant
Entravision, Inc.
641 Nuway Cir.
P.O. Box 1738
Lenoir,  NC  28645
Applicant Contact NEWTON, R.N.
Correspondent
Entravision, Inc.
641 Nuway Cir.
P.O. Box 1738
Lenoir,  NC  28645
Correspondent Contact NEWTON, R.N.
Regulation Number886.4670
Classification Product Code
HQC  
Date Received05/30/1986
Decision Date 06/19/1986
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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