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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K913811
Device Name FUKUDA DENSHI MODEL FCP-4101
Applicant
Fukuda Denshi USA, Inc.
7102-A 180th Ave. Northeast
Redmond,  WA  98052
Applicant Contact ROBERT J STEURER
Correspondent
Fukuda Denshi USA, Inc.
7102-A 180th Ave. Northeast
Redmond,  WA  98052
Correspondent Contact ROBERT J STEURER
Classification Product Code
LOS
Date Received08/26/1991
Decision Date 12/09/1991
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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