510(k) K180063

OCM-G1 Attachment by The Anspach Effort, Inc. — Product Code ERL

K180063 is an FDA 510(k) premarket notification submitted by The Anspach Effort, Inc. for the device "OCM-G1 Attachment". The FDA issued a decision of Substantially Equivalent on March 27, 2018. 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. The Anspach Effort, Inc. has at least 10 other 510(k) clearances on record.