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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 K932788
Device Name CORDIS BIPAL 7 BIOPSY FORCEPS WITH A INLINE HANDLE
Applicant
Cordis Corp.
14201 NW 60th Ave.
Miami Lakes,  FL  33014
Applicant Contact TAMARA HARDER
Correspondent
Cordis Corp.
14201 NW 60th Ave.
Miami Lakes,  FL  33014
Correspondent Contact TAMARA HARDER
Regulation Number870.4075
Classification Product Code
DWZ  
Date Received06/09/1993
Decision Date 09/01/1993
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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