510(k) K802522

DELTA-LITE CASTING TAPE & SPLINTS by Johnson & Johnson Professionals, Inc. — Product Code FYH

K802522 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Professionals, Inc. for the device "DELTA-LITE CASTING TAPE & SPLINTS". The FDA issued a decision of Substantially Equivalent on January 8, 1981. The device falls under product code FYH (Splint, Extremity, Noninflatable, External, Sterile), a Class I device regulated under 21 CFR 878.3910. Johnson & Johnson Professionals, Inc. has at least 10 other 510(k) clearances on record.