510(k) K820004

PLEUROFIX THORACENTESIS KIT by Burron Medical Products, Inc. — Product Code GAZ

K820004 is an FDA 510(k) premarket notification submitted by Burron Medical Products, Inc. for the device "PLEUROFIX THORACENTESIS KIT". The FDA issued a decision of Substantially Equivalent on February 4, 1982. The device falls under product code GAZ (Tubing, Noninvasive), a Class II device regulated under 21 CFR 880.6740. Burron Medical Products, Inc. has at least 10 other 510(k) clearances on record.