510(k) K980636

FIBER OPTIC ENDOILLUMINATION PROBE by Dutch Ophthalmic USA, Inc. — Product Code FFS

K980636 is an FDA 510(k) premarket notification submitted by Dutch Ophthalmic USA, Inc. for the device "FIBER OPTIC ENDOILLUMINATION PROBE". The FDA issued a decision of Substantially Equivalent on May 20, 1998. The device falls under product code FFS (Image, Illumination, Fiberoptic, For Endoscope), a Class II device regulated under 21 CFR 876.1500. Dutch Ophthalmic USA, Inc. has at least 9 other 510(k) clearances on record.