510(k) K062385

BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES by Grace Medical, Inc. — Product Code ETD

K062385 is an FDA 510(k) premarket notification submitted by Grace Medical, Inc. for the device "BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES". The FDA issued a decision of Substantially Equivalent on September 27, 2006. The device falls under product code ETD (Tube, Tympanostomy), a Class II device regulated under 21 CFR 874.3880. Grace Medical, Inc. has at least 10 other 510(k) clearances on record.