SUPERSKIN

Bandage, Liquid, Skin Protectant

MEDLOGIC GLOBAL CORP.

The following data is part of a premarket notification filed by Medlogic Global Corp. with the FDA for Superskin.

Pre-market Notification Details

• Device ID: K972081
• 510k Number: K972081
• Device Name: SUPERSKIN
• Classification: Bandage, Liquid, Skin Protectant
• Applicant: MEDLOGIC GLOBAL CORP. 1300 CONNECTICUT AVE, N.W. SUITE 1000 Washington, DC 20036
• Contact: Jur Strobos
• Correspondent: Jur Strobos; MEDLOGIC GLOBAL CORP. 1300 CONNECTICUT AVE, N.W. SUITE 1000 Washington, DC 20036
• Product Code: NEC
• CFR Regulation Number: 880.5090 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-06-03
• Decision Date: 1997-12-17
• Summary: summary