510(k) K954796

MICRO-INGRESSOR HANDIPIECE by Trebay Medical Corp. — Product Code ERL

K954796 is an FDA 510(k) premarket notification submitted by Trebay Medical Corp. for the device "MICRO-INGRESSOR HANDIPIECE". The FDA issued a decision of Substantially Equivalent on November 6, 1995. 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. Trebay Medical Corp. has at least 10 other 510(k) clearances on record.