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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 K871433
Device Name PPG BIOMEDICAL VENTILATOR MODEL AV 400
Applicant
Ppg Industries, Inc.
One Campus Dr.
Pleasantville,  NY  10570
Applicant Contact STEVE BRODY
Correspondent
Ppg Industries, Inc.
One Campus Dr.
Pleasantville,  NY  10570
Correspondent Contact STEVE BRODY
Regulation Number868.5895
Classification Product Code
CBK  
Date Received04/13/1987
Decision Date 05/29/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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