510(k) K923353

VENTILATION TUBES W/ HYDROGEL COATING by Microbio-Medics, Inc. — Product Code ETD

K923353 is an FDA 510(k) premarket notification submitted by Microbio-Medics, Inc. for the device "VENTILATION TUBES W/ HYDROGEL COATING". The FDA issued a decision of Substantially Equivalent on May 18, 1993. The device falls under product code ETD (Tube, Tympanostomy), a Class II device regulated under 21 CFR 874.3880. Microbio-Medics, Inc. has at least 10 other 510(k) clearances on record.