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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 K850275
Device Name KCP PAK #2 CONVENIENCE PACK MODIFICATION
Applicant
COOPERVISION, INC.
17701 COWAN AVE.P. O. BOX
19587
IRVINE,  CA  92713
Applicant Contact DAVID W DRAPF
Correspondent
COOPERVISION, INC.
17701 COWAN AVE.P. O. BOX
19587
IRVINE,  CA  92713
Correspondent Contact DAVID W DRAPF
Regulation Number886.4670
Classification Product Code
HQC  
Date Received01/23/1985
Decision Date 04/15/1985
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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