510(k) K153422

Panpac Disposable Pessary Fitting Set by Panpac Medical Corporation — Product Code HHW

K153422 is an FDA 510(k) premarket notification submitted by Panpac Medical Corporation for the device "Panpac Disposable Pessary Fitting Set". The FDA issued a decision of Substantially Equivalent on July 14, 2016. 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.