510(k) K864189

ULTRA-GEL - #4083 by John F. Greer Co., Inc. — Product Code EXB

K864189 is an FDA 510(k) premarket notification submitted by John F. Greer Co., Inc. for the device "ULTRA-GEL - #4083". The FDA issued a decision of Substantially Equivalent on December 4, 1986. The device falls under product code EXB (Collector, Ostomy), a Class I device regulated under 21 CFR 876.5900. John F. Greer Co., Inc. has at least 4 other 510(k) clearances on record.