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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Tubing And Support, Ventilator (W Harness)
510(k) Number K850600
Device Name CO-AX VENTILATOR CIRCUIT
Applicant
NOVA-VENTRX
500 GLENN AVE.
WHEELING,  IL  60090
Applicant Contact BERNARD R PALUCH
Correspondent
NOVA-VENTRX
500 GLENN AVE.
WHEELING,  IL  60090
Correspondent Contact BERNARD R PALUCH
Regulation Number868.5975
Classification Product Code
BZO  
Date Received02/15/1985
Decision Date 05/02/1985
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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