510(k) K884712

ESOPHAGEAL AND PYLORIC BALLOON DIALATORS by Primrose Medical, Inc. — Product Code KNQ

K884712 is an FDA 510(k) premarket notification submitted by Primrose Medical, Inc. for the device "ESOPHAGEAL AND PYLORIC BALLOON DIALATORS". The FDA issued a decision of Substantially Equivalent on September 8, 1989. The device falls under product code KNQ (Dilator, Esophageal), a Class II device regulated under 21 CFR 876.5365. Primrose Medical, Inc. has at least 10 other 510(k) clearances on record.