510(k) K891211

SURGICAL GOWN #2001 by Pro-Safe Professional Linens, Inc. — Product Code FYA

K891211 is an FDA 510(k) premarket notification submitted by Pro-Safe Professional Linens, Inc. for the device "SURGICAL GOWN #2001". The FDA issued a decision of Substantially Equivalent on April 14, 1989. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Pro-Safe Professional Linens, Inc. has at least 6 other 510(k) clearances on record.