510(k) K963777

HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100 by Stephenson Industries, Inc. — Product Code KPJ

K963777 is an FDA 510(k) premarket notification submitted by Stephenson Industries, Inc. for the device "HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100". The FDA issued a decision of Substantially Equivalent on July 28, 1997. The device falls under product code KPJ (Chamber, Oxygen, Topical, Extremity), a Class II device regulated under 21 CFR 878.5650. Stephenson Industries, Inc. has at least 3 other 510(k) clearances on record.