Cleared Traditional

K853640 - WELLINGTON HOSPITAL PATTERN SELF RETAINING VAGINAL
(FDA 510(k) Clearance)

K853640 · Downs Surgical , Ltd. · Obstetrics & Gynecology

Oct 1985

Decision

70d

Days

Class 1

Risk

K853640 is an FDA 510(k) clearance for the WELLINGTON HOSPITAL PATTERN SELF RETAINING VAGINAL. This device is classified as a Speculum, Vaginal, Metal (Class I — General Controls, product code HDF).

Submitted by Downs Surgical , Ltd. (Sheffield S9 4wj, GB). The FDA issued a Cleared decision on October 29, 1985, 70 days after receiving the submission on August 20, 1985.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4520.

Submission Details

510(k) Number	K853640 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 20, 1985
Decision Date	October 29, 1985
Days to Decision	70 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	—