Cleared Traditional

K940333 - EYE PAD
(FDA 510(k) Clearance)

K940333 · Certified Safety Mfg., Inc. · General & Plastic Surgery device

Mar 1994

Decision

41d

Days

Class 1

Risk

K940333 is an FDA 510(k) clearance for the EYE PAD. This device is classified as a Pad, Eye (Class I - General Controls, product code HMP).

Submitted by Certified Safety Mfg., Inc. (Kansas City, US). The FDA issued a Cleared decision on March 7, 1994, 41 days after receiving the submission on January 25, 1994.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4440.

Submission Details

510(k) Number	K940333 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 25, 1994
Decision Date	March 07, 1994
Days to Decision	41 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement