510(k) K963260

DRESSING CHANGE TRAYS by Busse Hospital Disposables, Inc. — Product Code FMF

K963260 is an FDA 510(k) premarket notification submitted by Busse Hospital Disposables, Inc. for the device "DRESSING CHANGE TRAYS". The FDA issued a decision of Substantially Equivalent on November 22, 1996. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Busse Hospital Disposables, Inc. has at least 10 other 510(k) clearances on record.