510(k) K872006

DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF by Mac Lee Medical Products — Product Code FGD

K872006 is an FDA 510(k) premarket notification submitted by Mac Lee Medical Products for the device "DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF". The FDA issued a decision of Substantially Equivalent on November 17, 1987. The device falls under product code FGD (Catheter, Retention, Barium Enema With Bag), a Class II device regulated under 21 CFR 876.5980. Mac Lee Medical Products has at least 10 other 510(k) clearances on record.