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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, continuous, facility use
510(k) Number K896442
Device Name PPG BIOMEDICAL VENTILATOR MODEL IRISA
Applicant
PPG INDUSTRIES, INC.
ONE CAMPUS DR.
PLEASANTVILLE,  NY  10570
Applicant Contact JOHN J TALARICO
Correspondent
PPG INDUSTRIES, INC.
ONE CAMPUS DR.
PLEASANTVILLE,  NY  10570
Correspondent Contact JOHN J TALARICO
Regulation Number868.5895
Classification Product Code
CBK  
Date Received11/09/1989
Decision Date 04/16/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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