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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 K822220
Device Name COOPER VISION I/A SYSTEM III MODEL 1500
Applicant
COOPERVISION, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
COOPERVISION, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number886.4150
Classification Product Code
HQE  
Date Received07/26/1982
Decision Date 10/06/1982
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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