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510(k) K973129

DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS by Denver Biomaterials, Inc. — Product Code KPM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1998
Date Received
August 21, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shunt, Peritoneal
Device Class
Class II
Regulation Number
876.5955
Review Panel
GU
Submission Type

Other clearances by Denver Biomaterials, Inc.

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  • K960456 — DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LIN (April 1, 1996)

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