510(k) K041579

MEDELA SINGLE USE SILC CUP, MODEL 077.0791 by Medela AG — Product Code HDB

K041579 is an FDA 510(k) premarket notification submitted by Medela AG for the device "MEDELA SINGLE USE SILC CUP, MODEL 077.0791". The FDA issued a decision of Substantially Equivalent on April 21, 2005. The device falls under product code HDB (Extractor, Vacuum, Fetal), a Class II device regulated under 21 CFR 884.4340. Medela AG has at least 10 other 510(k) clearances on record.