510(k) K800623

JACKSON ESOPHAGEAL BOUGIE, X-RAY OPAQUE by Pilling Co. — Product Code KCD

K800623 is an FDA 510(k) premarket notification submitted by Pilling Co. for the device "JACKSON ESOPHAGEAL BOUGIE, X-RAY OPAQUE". The FDA issued a decision of Substantially Equivalent on April 24, 1980. The device falls under product code KCD (Bougie, Esophageal, Ent), a Class I device regulated under 21 CFR 874.4420. Pilling Co. has at least 10 other 510(k) clearances on record.