510(k) K974025

ANSPACH SHIELDED ATTACHMENT by The Anspach Effort, Inc. — Product Code GFF

K974025 is an FDA 510(k) premarket notification submitted by The Anspach Effort, Inc. for the device "ANSPACH SHIELDED ATTACHMENT". The FDA issued a decision of Substantially Equivalent on July 6, 1998. The device falls under product code GFF (Bur, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4820. The Anspach Effort, Inc. has at least 10 other 510(k) clearances on record.