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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 K971753
Device Name DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500
Applicant
Denver Biomaterials, Inc.
14998 W. 6th Ave., Bldg. E700
Golden,  CO  80401
Applicant Contact LYNNE LEONARD
Correspondent
Denver Biomaterials, Inc.
14998 W. 6th Ave., Bldg. E700
Golden,  CO  80401
Correspondent Contact LYNNE LEONARD
Regulation Number870.5050
Classification Product Code
DWM  
Date Received05/12/1997
Decision Date 06/27/1997
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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