510(k) K893702

TECNOL GAITERS PRODUCT NUMBER 47725-010 by Tecnol New Jersey Wound Care, Inc. — Product Code FXP

K893702 is an FDA 510(k) premarket notification submitted by Tecnol New Jersey Wound Care, Inc. for the device "TECNOL GAITERS PRODUCT NUMBER 47725-010". The FDA issued a decision of Substantially Equivalent on June 23, 1989. The device falls under product code FXP (Cover, Shoe, Operating-Room), a Class I device regulated under 21 CFR 878.4040. Tecnol New Jersey Wound Care, Inc. has at least 10 other 510(k) clearances on record.