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510(k) K971753

DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500 by Denver Biomaterials, Inc. — Product Code DWM

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
June 27, 1997
Date Received
May 12, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Patient Care
Device Class
Class II
Regulation Number
870.5050
Review Panel
AN
Submission Type

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