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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 K943412
Device Name VENTURI VENTILATOR
Applicant
CARDIOPULMONARY CORP.
200 CASCADE BLVD.
MILFORD,  CT  06460
Applicant Contact JAMES W BIONDI
Correspondent
CARDIOPULMONARY CORP.
200 CASCADE BLVD.
MILFORD,  CT  06460
Correspondent Contact JAMES W BIONDI
Regulation Number868.5895
Classification Product Code
CBK  
Date Received07/14/1994
Decision Date 10/16/1995
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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