510(k) K914244

STERILE CUSTOM SURGICAL KITS by Ulti-Med Intl., Inc. — Product Code KDD

K914244 is an FDA 510(k) premarket notification submitted by Ulti-Med Intl., Inc. for the device "STERILE CUSTOM SURGICAL KITS". The FDA issued a decision of Substantially Equivalent (kit, denovo) on February 24, 1992. The device falls under product code KDD (Kit, Surgical Instrument, Disposable), a Class I device regulated under 21 CFR 878.4800. Ulti-Med Intl., Inc. has at least 10 other 510(k) clearances on record.