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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Circuit, Breathing (W Connector, Adaptor, Y Piece)
510(k) Number K954480
Device Name CONDENSATE COLLECTION KIT
Applicant
NOVA-VENTRX
1974 RAYMOND DR.
NORTHBROOK,  IL  60062
Applicant Contact BERNARD R PALUCH
Correspondent
NOVA-VENTRX
1974 RAYMOND DR.
NORTHBROOK,  IL  60062
Correspondent Contact BERNARD R PALUCH
Regulation Number868.5240
Classification Product Code
CAI  
Date Received09/26/1995
Decision Date 12/29/1995
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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