510(k) K893417

SURGIFRESH SUB-MICRON MASK NO. 901008-000 by Texas Medical Products, Inc. — Product Code FXX

K893417 is an FDA 510(k) premarket notification submitted by Texas Medical Products, Inc. for the device "SURGIFRESH SUB-MICRON MASK NO. 901008-000". The FDA issued a decision of Substantially Equivalent on June 22, 1989. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Texas Medical Products, Inc. has at least 10 other 510(k) clearances on record.