Cleared Traditional

K080200 - WATER WORKS DOUCHING DEVICE
(FDA 510(k) Clearance)

K080200 · Abbott Research Group, Inc. · Obstetrics & Gynecology device

Jul 2008

Decision

167d

Days

Class 1

Risk

K080200 is an FDA 510(k) clearance for the WATER WORKS DOUCHING DEVICE. This device is classified as a Douche Apparatus, Vaginal, Therapeutic (Class I - General Controls, product code HED).

Submitted by Abbott Research Group, Inc. (North Attleboro, US). The FDA issued a Cleared decision on July 10, 2008, 167 days after receiving the submission on January 25, 2008.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5900.

Submission Details

510(k) Number	K080200 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 25, 2008
Decision Date	July 10, 2008
Days to Decision	167 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF