510(k) K970965

MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III) by Midas Rex Pneumatic Tools, Inc. — Product Code ERL

K970965 is an FDA 510(k) premarket notification submitted by Midas Rex Pneumatic Tools, Inc. for the device "MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III)". The FDA issued a decision of Substantially Equivalent on April 9, 1997. The device falls under product code ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece), a Class II device regulated under 21 CFR 874.4250. Midas Rex Pneumatic Tools, Inc. has at least 10 other 510(k) clearances on record.