510(k) K871628

PALEX (R) OSTOMY by Industrias Palex C/O Dma Med-Chem Corp. — Product Code EXB

K871628 is an FDA 510(k) premarket notification submitted by Industrias Palex C/O Dma Med-Chem Corp. for the device "PALEX (R) OSTOMY". The FDA issued a decision of Substantially Equivalent on July 8, 1987. The device falls under product code EXB (Collector, Ostomy), a Class I device regulated under 21 CFR 876.5900. Industrias Palex C/O Dma Med-Chem Corp. has at least 4 other 510(k) clearances on record.