Cleared Traditional

K925754 - ECONOM (FDA 510(k) Clearance)

K925754 · Rudolf Riester GmbH & Co. KG · General & Plastic Surgery device

Oct 1993

Decision

329d

Days

Class 1

Risk

K925754 is an FDA 510(k) clearance for the ECONOM. This device is classified as a Speculum, Ent (Class I - General Controls, product code EPY).

Submitted by Rudolf Riester GmbH & Co. KG (D-72417 Jungingen, DE). The FDA issued a Cleared decision on October 8, 1993, 329 days after receiving the submission on November 13, 1992.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.1800.

Submission Details

510(k) Number	K925754 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 13, 1992
Decision Date	October 08, 1993
Days to Decision	329 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement