510(k) K991595

ORIBRUSH - WITH PROTECTIVE TIP - B001 by Orifice Medical AB — Product Code HHT

K991595 is an FDA 510(k) premarket notification submitted by Orifice Medical AB for the device "ORIBRUSH - WITH PROTECTIVE TIP - B001". The FDA issued a decision of Substantially Equivalent on June 29, 1999. The device falls under product code HHT (Spatula, Cervical, Cytological), a Class II device regulated under 21 CFR 884.4530. Orifice Medical AB has at least 1 other 510(k) clearance on record.