510(k) K041711

ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304 by Applied Medical Resources Corp. — Product Code KGW

K041711 is an FDA 510(k) premarket notification submitted by Applied Medical Resources Corp. for the device "ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304". The FDA issued a decision of Substantially Equivalent on August 26, 2004. The device falls under product code KGW (Ring (Wound Protector), Drape Retention, Internal), a Class II device regulated under 21 CFR 878.4370. Applied Medical Resources Corp. has at least 10 other 510(k) clearances on record.