510(k) K955064

SPETZLER TI 100 ANEURYSM CLIP by Elekta Instruments, Inc. — Product Code HCH

K955064 is an FDA 510(k) premarket notification submitted by Elekta Instruments, Inc. for the device "SPETZLER TI 100 ANEURYSM CLIP". The FDA issued a decision of Substantially Equivalent on October 17, 1996. The device falls under product code HCH (Clip, Aneurysm), a Class II device regulated under 21 CFR 882.5200. Elekta Instruments, Inc. has at least 7 other 510(k) clearances on record.