510(k) K810291

STERILE/DISPOSABLE HSG TRAY by Unimar, Inc. — Product Code EYY

K810291 is an FDA 510(k) premarket notification submitted by Unimar, Inc. for the device "STERILE/DISPOSABLE HSG TRAY". The FDA issued a decision of Substantially Equivalent on March 18, 1981. The device falls under product code EYY (Drape, Urological, Disposable), a Class II device regulated under 21 CFR 878.4370. Unimar, Inc. has at least 9 other 510(k) clearances on record.