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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valve, Non-Rebreathing
510(k) Number K870382
Device Name DRV DISP RESUSCIT 3000/BAG ADAPT 3010 & 3011
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 Number868.5870
Classification Product Code
CBP  
Date Received01/29/1987
Decision Date 03/06/1987
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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