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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K870443
Device Name KENZ-CARDICO 1201
Applicant
Suzuken Co., Ltd.
8549 Higuera St.
Culver City,  CA  90232
Applicant Contact MCSHARRY
Correspondent
Suzuken Co., Ltd.
8549 Higuera St.
Culver City,  CA  90232
Correspondent Contact MCSHARRY
Classification Product Code
LOS
Date Received02/03/1987
Decision Date 07/01/1987
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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