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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 K894286
Device Name PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER
Applicant
PPG INDUSTRIES, INC.
ONE CAMPUS DR.
PLEASANTVILLE,  NY  10570
Applicant Contact JOHN TALARICO
Correspondent
PPG INDUSTRIES, INC.
ONE CAMPUS DR.
PLEASANTVILLE,  NY  10570
Correspondent Contact JOHN TALARICO
Regulation Number870.2870
Classification Product Code
DXO  
Date Received06/23/1989
Decision Date 10/12/1989
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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