510(k) K821080

HAND KERATOSCOPE by Medical Equipment Designs, Inc. — Product Code HLR

K821080 is an FDA 510(k) premarket notification submitted by Medical Equipment Designs, Inc. for the device "HAND KERATOSCOPE". The FDA issued a decision of Substantially Equivalent on May 24, 1982. The device falls under product code HLR (Keratoscope, Battery-Powered), a Class I device regulated under 21 CFR 886.1350. Medical Equipment Designs, Inc. has at least 10 other 510(k) clearances on record.