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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name apparatus, suction, patient care
510(k) Number K051084
Device Name DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE
Applicant
DENVER BIOMEDICALS, INC.
433 PARK POINT DRIVE, SUITE 14
GOLDEN,  CO  80401
Applicant Contact NANCY SAUER
Correspondent
DENVER BIOMEDICALS, INC.
433 PARK POINT DRIVE, SUITE 14
GOLDEN,  CO  80401
Correspondent Contact NANCY SAUER
Regulation Number870.5050
Classification Product Code
DWM  
Date Received04/28/2005
Decision Date 06/13/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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