510(k) K843186

ESKA MULTISTAGE ESOPHAGEAL BOUGIE by Dacomed Corp. — Product Code FAT

K843186 is an FDA 510(k) premarket notification submitted by Dacomed Corp. for the device "ESKA MULTISTAGE ESOPHAGEAL BOUGIE". The FDA issued a decision of Substantially Equivalent on January 18, 1985. The device falls under product code FAT (Bougie, Esophageal, And Gastrointestinal, Gastro-Urology), a Class II device regulated under 21 CFR 876.5365. Dacomed Corp. has at least 10 other 510(k) clearances on record.