510(k) K991042

ASH ADVANTAGE PERITONEAL CATHETER by Janin Group, Inc. — Product Code FJS

K991042 is an FDA 510(k) premarket notification submitted by Janin Group, Inc. for the device "ASH ADVANTAGE PERITONEAL CATHETER". The FDA issued a decision of Substantially Equivalent on June 25, 1999. The device falls under product code FJS (Catheter, Peritoneal, Long-Term Indwelling), a Class II device regulated under 21 CFR 876.5630. Janin Group, Inc. has at least 4 other 510(k) clearances on record.