Cleared Traditional

K926540 - SOPHER AND BIERER OVUM FORCEPS
(FDA 510(k) Clearance)

K926540 · Thomasville Medical Assoc. · Ophthalmic device

Feb 1994

Decision

422d

Days

Class 2

Risk

K926540 is an FDA 510(k) clearance for the SOPHER AND BIERER OVUM FORCEPS. This device is classified as a Electrode, Corneal (Class II - Special Controls, product code HLZ).

Submitted by Thomasville Medical Assoc. (Alpharetta, US). The FDA issued a Cleared decision on February 25, 1994, 422 days after receiving the submission on December 30, 1992.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1220.

Submission Details

510(k) Number	K926540 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 30, 1992
Decision Date	February 25, 1994
Days to Decision	422 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement