510(k) K881084

UTILITY CLAMP by Med-Dex Intl. — Product Code GDJ

K881084 is an FDA 510(k) premarket notification submitted by Med-Dex Intl. for the device "UTILITY CLAMP". The FDA issued a decision of Substantially Equivalent on March 25, 1988. The device falls under product code GDJ (Clamp, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Med-Dex Intl. has at least 3 other 510(k) clearances on record.