510(k) K803171

PROCEDURE & RECOVERY PATIENT SUIT by Alba Health Care — Product Code FYB

K803171 is an FDA 510(k) premarket notification submitted by Alba Health Care for the device "PROCEDURE & RECOVERY PATIENT SUIT". The FDA issued a decision of Substantially Equivalent on March 4, 1981. The device falls under product code FYB (Gown, Patient), a Class II device regulated under 21 CFR 878.4040. Alba Health Care has at least 7 other 510(k) clearances on record.