510(k) K821084

UNIVERSAL TRIAL FRAMEE by Medical Equipment Designs, Inc. — Product Code HPA

K821084 is an FDA 510(k) premarket notification submitted by Medical Equipment Designs, Inc. for the device "UNIVERSAL TRIAL FRAMEE". The FDA issued a decision of Substantially Equivalent on June 14, 1982. The device falls under product code HPA (Frame, Trial, Ophthalmic), a Class I device regulated under 21 CFR 886.1415. Medical Equipment Designs, Inc. has at least 10 other 510(k) clearances on record.