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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 K002722
Device Name DIGITAL BLOOD PRESSURE MONITOR, MODELS HD-503 AND HD-505
Applicant
Jawon Medical Co., Ltd.
7f Jeong Ju Bldg.
Seocho-Dong. Seocho-Ku
Seoul,  KR 1451-38
Applicant Contact WON-HEE PARK
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607
Correspondent Contact ROBERT BOONSTRA
Regulation Number870.1130
Classification Product Code
DXN  
Date Received08/31/2000
Decision Date 09/11/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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