510(k) K173351

Panpac Flexi Shelf Pessary by Panpac Medical Corporation — Product Code HHW

K173351 is an FDA 510(k) premarket notification submitted by Panpac Medical Corporation for the device "Panpac Flexi Shelf Pessary". The FDA issued a decision of Substantially Equivalent on October 31, 2018. The device falls under product code HHW (Pessary, Vaginal), a Class II device regulated under 21 CFR 884.3575. Panpac Medical Corporation has at least 10 other 510(k) clearances on record.