510(k) K961711

ASPISAFE GASTRIC TUBE by B.Braun Medical, Inc. — Product Code BSS

K961711 is an FDA 510(k) premarket notification submitted by B.Braun Medical, Inc. for the device "ASPISAFE GASTRIC TUBE". The FDA issued a decision of Substantially Equivalent on June 11, 1997. The device falls under product code BSS (Tube, Nasogastric), a Class II device regulated under 21 CFR 876.5980. B.Braun Medical, Inc. has at least 10 other 510(k) clearances on record.