LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS9030

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 Limitorr Volume Limiting External Csf Drainage And Monitoring System, Models Ins9020, Ins9030.

Pre-market Notification Details

• Device ID: K072929
• 510k Number: K072929
• Device Name: LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS9030
• Classification: Shunt, Central Nervous System And Components
• Applicant: INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08536
• Contact: Darlene M Welsh
• Correspondent: Darlene M Welsh; INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08536
• Product Code: JXG
• CFR Regulation Number: 882.5550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-10-16
• Decision Date: 2007-12-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10381780071136	K072929	000
10381780071129	K072929	000
10381780071112	K072929	000
10381780071105	K072929	000
10381780071051	K072929	000