Cleared Traditional

K950913 - PERFECT, ENT SET, PRAKTIKANT, DE LUXE
(FDA 510(k) Clearance)

K950913 · Rudolf Riester GmbH & Co. KG · Ear, Nose, Throat device

May 1995

Decision

78d

Days

Class 1

Risk

K950913 is an FDA 510(k) clearance for the PERFECT, ENT SET, PRAKTIKANT, DE LUXE. This device is classified as a Otoscope (Class I - General Controls, product code ERA).

Submitted by Rudolf Riester GmbH & Co. KG (D-72417 Jungingen, DE). The FDA issued a Cleared decision on May 12, 1995, 78 days after receiving the submission on February 23, 1995.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4770.

Submission Details

510(k) Number	K950913 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 23, 1995
Decision Date	May 12, 1995
Days to Decision	78 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement