510(k) K842572

GAUZE & LAB SPONGES STERILE & NON by Ulti-Med Intl., Inc. — Product Code GDY

K842572 is an FDA 510(k) premarket notification submitted by Ulti-Med Intl., Inc. for the device "GAUZE & LAB SPONGES STERILE & NON". The FDA issued a decision of Substantially Equivalent on August 15, 1984. The device falls under product code GDY (Gauze/Sponge, Internal, X-Ray Detectable), a Class I device regulated under 21 CFR 878.4450. Ulti-Med Intl., Inc. has at least 10 other 510(k) clearances on record.