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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 K980845
Device Name MS-900S, MS-900SPM & MS-900SFM
Applicant
Mars Medical Products
P.O. Box 4341
Crofton,  MD  21114
Applicant Contact E J SMITH
Correspondent
Mars Medical Products
P.O. Box 4341
Crofton,  MD  21114
Correspondent Contact E J SMITH
Regulation Number870.1130
Classification Product Code
DXN  
Date Received03/04/1998
Decision Date 12/14/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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