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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Blood-Pressure, Extravascular
510(k) Number K904601
Device Name ADVANCE DISPOSABLE PRESSURE TRANSDUCER
Applicant
Advance Medical Designs, Inc.
808 Pickens Industrial Dr.
Marietta,  GA  30062
Applicant Contact D ARKIN
Correspondent
Advance Medical Designs, Inc.
808 Pickens Industrial Dr.
Marietta,  GA  30062
Correspondent Contact D ARKIN
Regulation Number870.2850
Classification Product Code
DRS  
Date Received10/10/1990
Decision Date 12/17/1990
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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