510(k) K984448

BIRCOLL BALLOON DISSECTOR by Wells Johnson Co. — Product Code FZW

K984448 is an FDA 510(k) premarket notification submitted by Wells Johnson Co. for the device "BIRCOLL BALLOON DISSECTOR". The FDA issued a decision of Substantially Equivalent on January 28, 1999. The device falls under product code FZW (Expander, Surgical, Skin Graft), a Class I device regulated under 21 CFR 878.4800. Wells Johnson Co. has at least 10 other 510(k) clearances on record.