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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 K003415
Device Name ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE
Applicant
Wang & Li, Inc.
2026 Coyle St.
Brooklyn,  NY  11229
Applicant Contact ANN D MCGONIGLE
Correspondent
Wang & Li, Inc.
2026 Coyle St.
Brooklyn,  NY  11229
Correspondent Contact ANN D MCGONIGLE
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received11/02/2000
Decision Date 01/03/2001
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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