510(k) K994191

SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T by Nmt Medical, Inc. — Product Code HCI

K994191 is an FDA 510(k) premarket notification submitted by Nmt Medical, Inc. for the device "SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T". The FDA issued a decision of Substantially Equivalent on February 8, 2000. The device falls under product code HCI (Applier, Aneurysm Clip), a Class II device regulated under 21 CFR 882.4175. Nmt Medical, Inc. has at least 1 other 510(k) clearance on record.