Cleared Traditional

K092227 - JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS
(FDA 510(k) Clearance)

K092227 · Integra Lifesciences Corp. · Neurology

Feb 2010

Decision

209d

Days

Class 2

Risk

K092227 is an FDA 510(k) clearance for the JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS, a Rongeur, Manual (Class II — Special Controls, product code HAE), submitted by Integra Lifesciences Corp. (York, US). The FDA issued a Cleared decision on February 17, 2010, 209 days after receiving the submission on July 23, 2009. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4840.

Submission Details

510(k) Number	K092227 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 23, 2009
Decision Date	February 17, 2010
Days to Decision	209 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF