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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Vitreous Aspiration And Cutting, Ac-Powered
510(k) Number K870775
Device Name ENTRAVISION MODECO II VITREOUS CUTTING HANDPIECE
Applicant
Entravision, Inc.
641 Nuway Cir.
P.O. Box 1738
Lenoir,  NC  28645
Applicant Contact NEWTON, RN
Correspondent
Entravision, Inc.
641 Nuway Cir.
P.O. Box 1738
Lenoir,  NC  28645
Correspondent Contact NEWTON, RN
Regulation Number886.4150
Classification Product Code
HQE  
Date Received02/26/1987
Decision Date 03/26/1987
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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