510(k) K980600

D903 AVANT ADULT HOLLOW FIBER OXYGENATOR by Dideco S.P.A. — Product Code JOW

K980600 is an FDA 510(k) premarket notification submitted by Dideco S.P.A. for the device "D903 AVANT ADULT HOLLOW FIBER OXYGENATOR". The FDA issued a decision of Substantially Equivalent on Aug 12, 1998. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Dideco S.P.A. has 32 other 510(k) clearances on record.