510(k) K913784

DOBBHOFF(R) SINGLE PASS PEG KIT by Biosearch Medical Products, Inc. — Product Code KNT

K913784 is an FDA 510(k) premarket notification submitted by Biosearch Medical Products, Inc. for the device "DOBBHOFF(R) SINGLE PASS PEG KIT". The FDA issued a decision of Substantially Equivalent (kit, denovo) on January 15, 1992. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Biosearch Medical Products, Inc. has at least 10 other 510(k) clearances on record.