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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Knife, Ophthalmic
510(k) Number K853063
Device Name SMARTKNIFE SYSTEM
Applicant
COOPERVISION, INC.
17701 COWAN AVE.P. O. BOX
19587
IRVINE,  CA  92713
Applicant Contact DAVID W KRAPF
Correspondent
COOPERVISION, INC.
17701 COWAN AVE.P. O. BOX
19587
IRVINE,  CA  92713
Correspondent Contact DAVID W KRAPF
Regulation Number886.4350
Classification Product Code
HNN  
Date Received07/19/1985
Decision Date 11/04/1985
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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