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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biopsy, Endomyocardial
510(k) Number K933235
Device Name CORDIS BIPAL 7 /BIOPSY & BIPAL BIOPSY FORCEPS, MODIF
Applicant
Cordis Corp.
P.O. Box 025700
Miami,  FL  33102
Applicant Contact TAMARA HARDER
Correspondent
Cordis Corp.
P.O. Box 025700
Miami,  FL  33102
Correspondent Contact TAMARA HARDER
Regulation Number870.4075
Classification Product Code
DWZ  
Date Received05/19/1993
Decision Date 01/06/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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