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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 K010686
Device Name KTJ-20C BLOOD PRESSURE CUFF, MODEL KTJ-20C
Applicant
Golden Horse Medical Equipment (Wuxi) Co. , Ltd.
1156 E. Ridgewood Ave.
P.O. Box 1211
Ridgewood,  NJ  07451
Applicant Contact GARY C BAUMAN
Correspondent
Entela, Inc.
3033 Madison Ave., SE
Grand Rapids,  MI  49548
Correspondent Contact N.E. DEVINE, JR.
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received03/08/2001
Decision Date 03/21/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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