Cleared Traditional

K092981 - PANPAC VAGINAL PESSARY (FDA 510(k) Clearance)

K092981 · Panpac Medical Corporation · Obstetrics & Gynecology device

Jul 2010

Decision

297d

Days

Class 2

Risk

K092981 is an FDA 510(k) clearance for the PANPAC VAGINAL PESSARY. This device is classified as 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 July 22, 2010, 297 days after receiving the submission on September 28, 2009.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.3575.

Submission Details

510(k) Number	K092981 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 28, 2009
Decision Date	July 22, 2010
Days to Decision	297 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Statement