Gel-e Flex

Dressing, Wound, Drug

Gel-e, Inc.

The following data is part of a premarket notification filed by Gel-e, Inc. with the FDA for Gel-e Flex.

Pre-market Notification Details

• Device ID: K180152
• 510k Number: K180152
• Device Name: Gel-e Flex
• Classification: Dressing, Wound, Drug
• Applicant: gel-e, Inc. 387 Technology Dr., Suite 3110B College Park, MD 20742
• Contact: Elsa Abruzzo
• Correspondent: Elsa Abruzzo; gel-e, Inc. 387 Technology Dr., Suite 3110B College Park, MD 20742
• Product Code: FRO
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2018-01-19
• Decision Date: 2018-06-22