Cleared Traditional

K854595 - P.A. MEDICAL VAGINAL IRRIGATION SET #1130
(FDA 510(k) Clearance)

K854595 · Pa Medical Corp. · Obstetrics & Gynecology device

Jan 1986

Decision

56d

Days

Class 1

Risk

K854595 is an FDA 510(k) clearance for the P.A. MEDICAL VAGINAL IRRIGATION SET #1130. This device is classified as a Douche Apparatus, Vaginal, Therapeutic (Class I - General Controls, product code HED).

Submitted by Pa Medical Corp. (Columbia, US). The FDA issued a Cleared decision on January 13, 1986, 56 days after receiving the submission on November 18, 1985.

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

Submission Details

510(k) Number	K854595 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 18, 1985
Decision Date	January 13, 1986
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	—