Cleared Traditional

LANGGASSE 90

K932470 · Happersberger Otopront GmbH · Ear, Nose, Throat

Aug 1993

Decision

97d

Days

Class 1

Risk

About This 510(k) Submission

K932470 is an FDA 510(k) clearance for the LANGGASSE 90, a Unit, Examining/treatment, Ent (Class I — General Controls, product code ETF), submitted by Happersberger Otopront GmbH (Germany, GR). The FDA issued a Cleared decision on August 25, 1993, 97 days after receiving the submission on May 20, 1993. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.5300.

Submission Details

510(k) Number	K932470 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 20, 1993
Decision Date	August 25, 1993
Days to Decision	97 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement