Cleared Special

K030289 - HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700, NL850-830N
(FDA 510(k) Clearance)

K030289 · Integra Lifesciences Corp. · Neurology

Feb 2003

Decision

29d

Days

Class 2

Risk

K030289 is an FDA 510(k) clearance for the HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700, NL850-830N, a Shunt, Central Nervous System And Components (Class II — Special Controls, product code JXG), submitted by Integra Lifesciences Corp. (Planisboro, US). The FDA issued a Cleared decision on February 26, 2003, 29 days after receiving the submission on January 28, 2003. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5550.

Submission Details

510(k) Number	K030289 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 28, 2003
Decision Date	February 26, 2003
Days to Decision	29 days
Submission Type	Special
Review Panel	Neurology (NE)
Summary	Summary PDF