Cleared Traditional

K904896 - EYE PAD
(FDA 510(k) Clearance)

K904896 · Ulti-Med Intl., Inc. · General & Plastic Surgery device

Dec 1990

Decision

36d

Days

Class 1

Risk

K904896 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 Ulti-Med Intl., Inc. (Glendale Hts., US). The FDA issued a Cleared decision on December 5, 1990, 36 days after receiving the submission on October 30, 1990.

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

Submission Details

510(k) Number	K904896 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 30, 1990
Decision Date	December 05, 1990
Days to Decision	36 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—