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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 K852978
Device Name COMFORT - CUF
Applicant
Dynasty Instruments, Ltd.
724 Puesta Del Sol
Indialantic,  FL  32903
Applicant Contact JAMES L SIMPSON
Correspondent
Dynasty Instruments, Ltd.
724 Puesta Del Sol
Indialantic,  FL  32903
Correspondent Contact JAMES L SIMPSON
Regulation Number870.1130
Classification Product Code
DXN  
Date Received07/15/1985
Decision Date 01/14/1986
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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