510(k) K854118

DACOMED CORP. ESKA-HERRMAN VOICE PROSTHESIS by Dacomed Corp. — Product Code EWL

K854118 is an FDA 510(k) premarket notification submitted by Dacomed Corp. for the device "DACOMED CORP. ESKA-HERRMAN VOICE PROSTHESIS". The FDA issued a decision of Substantially Equivalent on March 17, 1986. The device falls under product code EWL (Prosthesis, Laryngeal (Taub)), a Class II device regulated under 21 CFR 874.3730. Dacomed Corp. has at least 10 other 510(k) clearances on record.