510(k) K961754

SAFETY RELEASE MODULE by G & H Wire Co. — Product Code DZB

K961754 is an FDA 510(k) premarket notification submitted by G & H Wire Co. for the device "SAFETY RELEASE MODULE". The FDA issued a decision of Substantially Equivalent on July 10, 1996. The device falls under product code DZB (Headgear, Extraoral, Orthodontic), a Class II device regulated under 21 CFR 872.5500. G & H Wire Co. has at least 1 other 510(k) clearance on record.