510(k) K891214

DENTAL SURGICAL WRAP #3007 A,B,C by Pro-Safe Professional Linens, Inc. — Product Code KCT

K891214 is an FDA 510(k) premarket notification submitted by Pro-Safe Professional Linens, Inc. for the device "DENTAL SURGICAL WRAP #3007 A,B,C". The FDA issued a decision of Substantially Equivalent on April 14, 1989. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Pro-Safe Professional Linens, Inc. has at least 6 other 510(k) clearances on record.