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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 K010642
Device Name PLEURX PLEURAL CATHETER AND DRAINAGE KITS
Applicant
DENVER BIOMEDICALS, INC.
14998 W. 6TH AVE., BLDG. E700
GOLDEN,  CO  80401
Applicant Contact NANCY SAUER
Correspondent
DENVER BIOMEDICALS, INC.
14998 W. 6TH AVE., BLDG. E700
GOLDEN,  CO  80401
Correspondent Contact NANCY SAUER
Regulation Number870.5050
Classification Product Code
DWM  
Date Received03/05/2001
Decision Date 03/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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