Cleared Traditional

SAPHIRE PLUS SURGICAL MIRROR

K934911 · San Diego Swiss Machining, Inc. · Ear, Nose, Throat

Jun 1994

Decision

250d

Days

Class 1

Risk

About This 510(k) Submission

K934911 is an FDA 510(k) clearance for the SAPHIRE PLUS SURGICAL MIRROR, a Source, Carrier, Fiberoptic Light (Class I — General Controls, product code EQH), submitted by San Diego Swiss Machining, Inc. (San Diego, US). The FDA issued a Cleared decision on June 21, 1994, 250 days after receiving the submission on October 14, 1993. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4350.

Submission Details

510(k) Number	K934911 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 14, 1993
Decision Date	June 21, 1994
Days to Decision	250 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement