DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500

Apparatus, Suction, Patient Care

DENVER BIOMATERIALS, INC.

The following data is part of a premarket notification filed by Denver Biomaterials, Inc. with the FDA for Denver Pleurx Pleural Catheter Kit, Catalog No. 50-7000, Denver Pleurx Home Drainage Kit, Catalog No. 50-7500.

Pre-market Notification Details

Device IDK971753
510k NumberK971753
Device Name:DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500
ClassificationApparatus, Suction, Patient Care
Applicant DENVER BIOMATERIALS, INC. 14998 W. 6TH AVE. BLDG. E700 Golden,  CO  80401
ContactLynne Leonard
CorrespondentLynne Leonard
DENVER BIOMATERIALS, INC. 14998 W. 6TH AVE. BLDG. E700 Golden,  CO  80401
Product CodeDWM  
CFR Regulation Number870.5050 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-05-12
Decision Date1997-06-27
Summary:summary

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