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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 K884919
Device Name DISPOSABLE DOME STOCK #D-300
Applicant
Advanced Medical, Inc.
17744 Sampson Ln.-Unit 7
Huntington Beach,  CA  92647
Applicant Contact VICTOR H PEREIRA
Correspondent
Advanced Medical, Inc.
17744 Sampson Ln.-Unit 7
Huntington Beach,  CA  92647
Correspondent Contact VICTOR H PEREIRA
Regulation Number870.2850
Classification Product Code
DRS  
Date Received11/28/1988
Decision Date 01/05/1989
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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