510(k) K122494

POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT by Hemostasis, LLC — Product Code LYA

K122494 is an FDA 510(k) premarket notification submitted by Hemostasis, LLC for the device "POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT". The FDA issued a decision of Substantially Equivalent on March 27, 2013. The device falls under product code LYA (Splint, Intranasal Septal), a Class I device regulated under 21 CFR 874.4780. Hemostasis, LLC has at least 9 other 510(k) clearances on record.