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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K003282
Device Name FULL AUTO BLOOD PRESSURE MONITOR, MODEL SE-7700H
Applicant
Sein Electronics Co., Ltd.
196 Anyang 7 Dong, Manan-Ku
Youcheon Factopia Rm. #506
Anyang-City, Kyungki-Do,  KR 206
Applicant Contact WON KY KIM
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Correspondent Contact ROBERT BOONSTRA
Regulation Number870.1130
Classification Product Code
DXN  
Date Received10/19/2000
Decision Date 11/01/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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