ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM

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 Accudrain External Csf Drainage System.

Pre-market Notification Details

• Device ID: K042825
• 510k Number: K042825
• Device Name: ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM
• Classification: Shunt, Central Nervous System And Components
• Applicant: INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08536
• Contact: Darlene M Walsh
• Correspondent: Darlene M Walsh; INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. 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: 2004-10-12
• Decision Date: 2004-12-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10381780374121	K042825	000
10381780023876	K042825	000
10381780023883	K042825	000
10381780072041	K042825	000
10381780072058	K042825	000
10381780072065	K042825	000
10381780072072	K042825	000
10381780072089	K042825	000
10381780072096	K042825	000
10381780072102	K042825	000
10381780072119	K042825	000
10381780072126	K042825	000
10381780072133	K042825	000
10381780072140	K042825	000
10381780072171	K042825	000
10381780536291	K042825	000