510(k) K914784

PAPILLION PROCTOSCOPE by Oldelft Corp. of America — Product Code KQA

K914784 is an FDA 510(k) premarket notification submitted by Oldelft Corp. of America for the device "PAPILLION PROCTOSCOPE". The FDA issued a decision of Substantially Equivalent on June 5, 1992. The device falls under product code KQA (Device, Beam Limiting, X-Ray, Therapeutic), a Class II device regulated under 21 CFR 892.5900. Oldelft Corp. of America has at least 8 other 510(k) clearances on record.