510(k) K962163

MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL by Misten Medical Corp. — Product Code ERL

K962163 is an FDA 510(k) premarket notification submitted by Misten Medical Corp. for the device "MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL". The FDA issued a decision of Substantially Equivalent on July 25, 1996. 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. Misten Medical Corp. has at least 3 other 510(k) clearances on record.