510(k) K882128

TECNOL TIGER PAWS PRODUCT NUMBER 47705-010 by Tecnol New Jersey Wound Care, Inc. — Product Code FXP

K882128 is an FDA 510(k) premarket notification submitted by Tecnol New Jersey Wound Care, Inc. for the device "TECNOL TIGER PAWS PRODUCT NUMBER 47705-010". The FDA issued a decision of Substantially Equivalent on June 15, 1988. 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.