510(k) K910518

GLOVE-N-GEL AMNIOTOMY KIT by Epcom Medical Systems, Inc. — Product Code HGE

K910518 is an FDA 510(k) premarket notification submitted by Epcom Medical Systems, Inc. for the device "GLOVE-N-GEL AMNIOTOMY KIT". The FDA issued a decision of Substantially Equivalent (kit) on May 9, 1991. The device falls under product code HGE (Amniotome), a Class I device regulated under 21 CFR 884.4530. Epcom Medical Systems, Inc. has at least 10 other 510(k) clearances on record.