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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Pressure, Catheter Tip
510(k) Number K843969
Device Name MODEL P23XL PHYSIOLOGICAL PRESSURE TRANSDUCER
Applicant
Gould, Inc.
1900 Williams Dr.
Oxnard,  CA  93030
Applicant Contact ARCHER S GORDON
Correspondent
Gould, Inc.
1900 Williams Dr.
Oxnard,  CA  93030
Correspondent Contact ARCHER S GORDON
Regulation Number870.2870
Classification Product Code
DXO  
Date Received10/11/1984
Decision Date 01/23/1985
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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