Cleared Traditional

K974232 - ESSENTIAL SHAVER SYSTEM
(FDA 510(k) Clearance)

K974232 · Gyrus Ent LLC · Ear, Nose, Throat device

Jan 1998

Decision

61d

Days

Class 1

Risk

K974232 is an FDA 510(k) clearance for the ESSENTIAL SHAVER SYSTEM. This device is classified as a Bur, Ear, Nose And Throat (Class I - General Controls, product code EQJ).

Submitted by Gyrus Ent LLC (Bartlett, US). The FDA issued a Cleared decision on January 12, 1998, 61 days after receiving the submission on November 12, 1997.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4140.

Submission Details

510(k) Number	K974232 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 12, 1997
Decision Date	January 12, 1998
Days to Decision	61 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF