510(k) K943848

COLLAR BUTTON VENTURI VENT TUBE by Micromed Development Corp. — Product Code ETD

K943848 is an FDA 510(k) premarket notification submitted by Micromed Development Corp. for the device "COLLAR BUTTON VENTURI VENT TUBE". The FDA issued a decision of Substantially Equivalent on September 16, 1994. The device falls under product code ETD (Tube, Tympanostomy), a Class II device regulated under 21 CFR 874.3880. Micromed Development Corp. has at least 10 other 510(k) clearances on record.