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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blood Pressure Cuff
510(k) Number K901506
Device Name ANEROID SPHYGMOMANOMETER, DOCTOR TYPE
Applicant
Yamasu Co. , Ltd.
100 Nukui Kamikawa Mura
Kodama Gun
Saitama Pref.,  JP
Applicant Contact WATANABE
Correspondent
Yamasu Co. , Ltd.
100 Nukui Kamikawa Mura
Kodama Gun
Saitama Pref.,  JP
Correspondent Contact WATANABE
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received03/30/1990
Decision Date 05/09/1990
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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