Bundled Neurological Shunts And Accessories Product Families Labeling Modification To Support MR Conditional Labeling

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 Bundled Neurological Shunts And Accessories Product Families Labeling Modification To Support Mr Conditional Labeling.

Pre-market Notification Details

• Device ID: K153041
• 510k Number: K153041
• Device Name: Bundled Neurological Shunts And Accessories Product Families Labeling Modification To Support MR Conditional Labeling
• Classification: Shunt, Central Nervous System And Components
• Applicant: INTEGRA LIFESCIENCES CORPORATION 311 Enterprise Drive Plainsboro, NJ 08536
• Contact: Timothy Connors
• Correspondent: Timothy Connors; 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: 2015-10-19
• Decision Date: 2016-03-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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