HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700, NL850-830N

Shunt, Central Nervous System And Components

INTEGRA LIFESCIENCES CORP.

The following data is part of a premarket notification filed by Integra Lifesciences Corp. with the FDA for Hermetic Plus External Csf Drainage Systems, Ins-8301,ins-8302,ins-8700, Nl850-830n.

Pre-market Notification Details

• Device ID: K030289
• 510k Number: K030289
• Device Name: HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700, NL850-830N
• Classification: Shunt, Central Nervous System And Components
• Applicant: INTEGRA LIFESCIENCES CORP. 311 ENTERPRISE DR. Plainsboro, NJ 08536
• Contact: Donna Wallace
• Correspondent: Donna Wallace; INTEGRA LIFESCIENCES CORP. 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: 2003-01-28
• Decision Date: 2003-02-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10381780072034	K030289	000
10381780071983	K030289	000
10381780071976	K030289	000
30381780071017	K030289	000
10381780071006	K030289	000
10381780023869	K030289	000
10381780537434	K030289	000