510(k) K990388

TUTOPLUS IV ADMINISTRATION SET by Myco Medical Supplies, Inc. — Product Code FPA

K990388 is an FDA 510(k) premarket notification submitted by Myco Medical Supplies, Inc. for the device "TUTOPLUS IV ADMINISTRATION SET". The FDA issued a decision of Substantially Equivalent on March 29, 1999. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Myco Medical Supplies, Inc. has at least 10 other 510(k) clearances on record.