Cleared Special

Panpac Disposable Pessary Fitting Set

K153422 · Panpac Medical Corporation · Obstetrics & Gynecology
Jul 2016
Decision
232d
Days
Class 2
Risk

About This 510(k) Submission

K153422 is an FDA 510(k) clearance for the Panpac Disposable Pessary Fitting Set, a Pessary, Vaginal (Class II — Special Controls, product code HHW), submitted by Panpac Medical Corporation (Shi-Chih Dist., TW). The FDA issued a Cleared decision on July 14, 2016, 232 days after receiving the submission on November 25, 2015. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.3575.

Submission Details

510(k) Number K153422 FDA.gov
FDA Decision Cleared SESE
Date Received November 25, 2015
Decision Date July 14, 2016
Days to Decision 232 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

Device Classification

Product Code HHW — Pessary, Vaginal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.3575

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