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510(k) K981246

BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730) by Integra Neurocare, LLC — Product Code JXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1999
Date Received
April 6, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shunt, Central Nervous System And Components
Device Class
Class II
Regulation Number
882.5550
Review Panel
NE
Submission Type

Other clearances by Integra Neurocare, LLC

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  • K992006 — NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33 (August 17, 1999)
  • K973525 — MAURICE WORLDWIDE SHUNT SYSTEM (December 16, 1997)
  • K972994 — EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS (November 3, 1997)
  • K972261 — RIVETTI-LEVINSON INSTRALUMINAL SHUNT (September 15, 1997)
  • K971617 — ENDOSCOPIC VENTRICULAR CATHETER (July 31, 1997)
  • K970983 — PERITONEAL/CARDIAC CATHETER (June 13, 1997)
  • K970658 — LUMBAR DRAINAGE ACCESSORY KIT (May 19, 1997)
  • K964371 — SHUNT TAP WITH ICP MONITORING ACCESS PORT (January 31, 1997)
  • K961859 — NOVUS STANDARD AND PEDIATRIC VALVES (December 16, 1996)

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