510(k) K092227

JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS by Integra Lifesciences Corp. — Product Code HAE

K092227 is an FDA 510(k) premarket notification submitted by Integra Lifesciences Corp. for the device "JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS". The FDA issued a decision of Substantially Equivalent on February 17, 2010. The device falls under product code HAE (Rongeur, Manual), a Class II device regulated under 21 CFR 882.4840. Integra Lifesciences Corp. has at least 10 other 510(k) clearances on record.