510(k) K770137

NEGATIVE PRESSURE ADAPTER 5M1350 by Travenol Laboratories, S.A. — Product Code FIL

K770137 is an FDA 510(k) premarket notification submitted by Travenol Laboratories, S.A. for the device "NEGATIVE PRESSURE ADAPTER 5M1350". The FDA issued a decision of Substantially Equivalent on Feb 1, 1977. The device falls under product code FIL (System, Dialysate Delivery, Single Pass), a Class II device regulated under 21 CFR 876.5820. Travenol Laboratories, S.A. has 205 other 510(k) clearances on record.