510(k) K963492

PROTECTIVE RESTRAINT by Smith And Nephew Donjoy, Inc. — Product Code FMQ

K963492 is an FDA 510(k) premarket notification submitted by Smith And Nephew Donjoy, Inc. for the device "PROTECTIVE RESTRAINT". The FDA issued a decision of Substantially Equivalent on Nov 12, 1996. The device falls under product code FMQ (Restraint, Protective), a Class I device regulated under 21 CFR 880.6760. Smith And Nephew Donjoy, Inc. has 14 other 510(k) clearances on record.