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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cannula, surgical, general & plastic surgery
510(k) Number K872214
Device Name COOPER SURG ASPIRATION CANNULA/CUSTOM CONVEN PAKS
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 Number878.4800
Classification Product Code
GEA  
Date Received06/09/1987
Decision Date 08/17/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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