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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 K861380
Device Name SERIES TEN THOUSAND MASTER
Applicant
COOPERVISION, INC.
17701 COWAN AVE.P. O. BOX
19587
IRVINE,  CA  92713
Applicant Contact DONALD E PACKER
Correspondent
COOPERVISION, INC.
17701 COWAN AVE.P. O. BOX
19587
IRVINE,  CA  92713
Correspondent Contact DONALD E PACKER
Regulation Number886.4150
Classification Product Code
HQE  
Date Received04/14/1986
Decision Date 07/11/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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