510(k) K162284

Puritan Fecal Opti-Swab Collection and Transport System by Puritan Medical Products, LLC — Product Code JSM

K162284 is an FDA 510(k) premarket notification submitted by Puritan Medical Products, LLC for the device "Puritan Fecal Opti-Swab Collection and Transport System". The FDA issued a decision of Substantially Equivalent on November 4, 2016. The device falls under product code JSM (Culture Media, Non-Propagating Transport), a Class I device regulated under 21 CFR 866.2390. Puritan Medical Products, LLC has at least 6 other 510(k) clearances on record.