510(k) K813616

TEKNA MED MYRINGOTOMY DISPOS-OTO KIT by Humboldt Products — Product Code ETD

K813616 is an FDA 510(k) premarket notification submitted by Humboldt Products for the device "TEKNA MED MYRINGOTOMY DISPOS-OTO KIT". The FDA issued a decision of Substantially Equivalent on January 22, 1982. The device falls under product code ETD (Tube, Tympanostomy), a Class II device regulated under 21 CFR 874.3880. Humboldt Products has at least 4 other 510(k) clearances on record.