SCAR HEAL

Elastomer, Silicone, For Scar Management

SPECIALTY SYSTEMS, INC.

The following data is part of a premarket notification filed by Specialty Systems, Inc. with the FDA for Scar Heal.

Pre-market Notification Details

• Device ID: K971468
• 510k Number: K971468
• Device Name: SCAR HEAL
• Classification: Elastomer, Silicone, For Scar Management
• Applicant: SPECIALTY SYSTEMS, INC. 1312 VERACRUZ LN. Western, FL 33327
• Contact: Glenn R Joyner
• Correspondent: Glenn R Joyner; SPECIALTY SYSTEMS, INC. 1312 VERACRUZ LN. Western, FL 33327
• Product Code: MDA
• CFR Regulation Number: 878.4025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-04-22
• Decision Date: 1997-06-10