510(k) K891212

APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE by Pro-Safe Professional Linens, Inc. — Product Code FXO

K891212 is an FDA 510(k) premarket notification submitted by Pro-Safe Professional Linens, Inc. for the device "APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE". The FDA issued a decision of Substantially Equivalent on April 14, 1989. The device falls under product code FXO (Suit, Surgical), a Class I device regulated under 21 CFR 878.4040. Pro-Safe Professional Linens, Inc. has at least 6 other 510(k) clearances on record.