Integra DP Valve Systems (including Burr Hole Reservoirs And Stainless Steel Connectors), Gravity Compensating Accessory

Shunt, Central Nervous System And Components

INTEGRA LIFESCIENCES CORPORATION

The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Integra Dp Valve Systems (including Burr Hole Reservoirs And Stainless Steel Connectors), Gravity Compensating Accessory.

Pre-market Notification Details

• Device ID: K152897
• 510k Number: K152897
• Device Name: Integra DP Valve Systems (including Burr Hole Reservoirs And Stainless Steel Connectors), Gravity Compensating Accessory
• Classification: Shunt, Central Nervous System And Components
• Applicant: INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DRIVE Plainsboro, NJ 08536
• Contact: Jennifer Siegel
• Correspondent: Jennifer Siegel; INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DRIVE Plainsboro, NJ 08536
• Product Code: JXG
• CFR Regulation Number: 882.5550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-10-01
• Decision Date: 2016-03-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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