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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 K870186
Device Name ENDOMYOCARDIAL BIOPSY DEVICE
Applicant
MANSFIELD SCIENTIFIC, INC.
135 FORBES BLVD.
MANSFIELD,  MA  02048
Applicant Contact BRUCE BEAUCHEMIN
Correspondent
MANSFIELD SCIENTIFIC, INC.
135 FORBES BLVD.
MANSFIELD,  MA  02048
Correspondent Contact BRUCE BEAUCHEMIN
Regulation Number870.4075
Classification Product Code
DWZ  
Date Received01/16/1987
Decision Date 02/20/1987
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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