EYE PAD

Pad, Eye

ULTI-MED INTL., INC.

The following data is part of a premarket notification filed by Ulti-med Intl., Inc. with the FDA for Eye Pad.

Pre-market Notification Details

• Device ID: K904896
• 510k Number: K904896
• Device Name: EYE PAD
• Classification: Pad, Eye
• Applicant: ULTI-MED INTL., INC. 1688 GLEN ELLYN RD. Glendale Heights, IL 60139
• Contact: David Insco
• Correspondent: David Insco; ULTI-MED INTL., INC. 1688 GLEN ELLYN RD. Glendale Heights, IL 60139
• Product Code: HMP
• CFR Regulation Number: 878.4440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-10-30
• Decision Date: 1990-12-05