510(k) K822349

ARMSTRONG V TUBE SUCTION INSERTER by Treace Medical, Inc. — Product Code JYM

K822349 is an FDA 510(k) premarket notification submitted by Treace Medical, Inc. for the device "ARMSTRONG V TUBE SUCTION INSERTER". The FDA issued a decision of Substantially Equivalent on September 13, 1982. The device falls under product code JYM (Inserter, Myringotomy Tube), a Class I device regulated under 21 CFR 874.4420. Treace Medical, Inc. has at least 10 other 510(k) clearances on record.