510(k) K984017

ALLISON MEDICAL INSULIN SYRINGE (AMIS) by Allison Medical, Inc. — Product Code FMF

K984017 is an FDA 510(k) premarket notification submitted by Allison Medical, Inc. for the device "ALLISON MEDICAL INSULIN SYRINGE (AMIS)". The FDA issued a decision of Substantially Equivalent on March 4, 1999. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Allison Medical, Inc. has at least 1 other 510(k) clearance on record.