510(k) K801609

MADDOX LENS SPATULA CAT. #7245 by Edward Weck, Inc. — Product Code HND

K801609 is an FDA 510(k) premarket notification submitted by Edward Weck, Inc. for the device "MADDOX LENS SPATULA CAT. #7245". The FDA issued a decision of Substantially Equivalent on August 13, 1980. The device falls under product code HND (Spatula, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Edward Weck, Inc. has at least 10 other 510(k) clearances on record.