510(k) K143068

Medical Monofilament Sensory Screening Toool by Medical Monofilament Manufacturing — Product Code GXB

K143068 is an FDA 510(k) premarket notification submitted by Medical Monofilament Manufacturing for the device "Medical Monofilament Sensory Screening Toool". The FDA issued a decision of Substantially Equivalent on January 14, 2015. The device falls under product code GXB (Esthesiometer), a Class I device regulated under 21 CFR 882.1500.