Cleared Traditional

PANPAC INFLATABLE DOCUT PESSARY

K132670 · Panpac Medical Corporation · Obstetrics & Gynecology
Jun 2014
Decision
281d
Days
Class 2
Risk

About This 510(k) Submission

K132670 is an FDA 510(k) clearance for the PANPAC INFLATABLE DOCUT PESSARY, a Pessary, Vaginal (Class II — Special Controls, product code HHW), submitted by Panpac Medical Corporation (Shi-Chih City, Taipei Hsien, TW). The FDA issued a Cleared decision on June 4, 2014, 281 days after receiving the submission on August 27, 2013. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.3575.

Submission Details

510(k) Number K132670 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 2013
Decision Date June 04, 2014
Days to Decision 281 days
Submission Type Traditional
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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