510(k) K934610

CATH DOME PD- WATER RESISTANT COVER FOR INDWELLING PERITONEAL DIALYSIS CATHETERS AND TRANSFER SETS by Tabex Industries, Inc. — Product Code FJS

K934610 is an FDA 510(k) premarket notification submitted by Tabex Industries, Inc. for the device "CATH DOME PD- WATER RESISTANT COVER FOR INDWELLING PERITONEAL DIALYSIS CATHETERS AND TRANSFER SETS". The FDA issued a decision of Substantially Equivalent on September 23, 1994. The device falls under product code FJS (Catheter, Peritoneal, Long-Term Indwelling), a Class II device regulated under 21 CFR 876.5630. Tabex Industries, Inc. has at least 1 other 510(k) clearance on record.