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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 K831583
Device Name GP-303
Applicant
Hirata Sangyo Co. USA, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Hirata Sangyo Co. USA, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.1130
Classification Product Code
DXN  
Date Received05/17/1983
Decision Date 07/19/1983
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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