510(k) K970835

FACE MASK, SURGICAL MASK, NON-STERILE by Tucker & Associates — Product Code FXX

K970835 is an FDA 510(k) premarket notification submitted by Tucker & Associates for the device "FACE MASK, SURGICAL MASK, NON-STERILE". The FDA issued a decision of Substantially Equivalent on September 3, 1997. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Tucker & Associates has at least 3 other 510(k) clearances on record.