SCARAID SILICONE GEL SHEETING

Elastomer, Silicone, For Scar Management

BIODERMIS CORP.

The following data is part of a premarket notification filed by Biodermis Corp. with the FDA for Scaraid Silicone Gel Sheeting.

Pre-market Notification Details

• Device ID: K992146
• 510k Number: K992146
• Device Name: SCARAID SILICONE GEL SHEETING
• Classification: Elastomer, Silicone, For Scar Management
• Applicant: BIODERMIS CORP. 3078 EAST SUNSET RD. SUITE #1 Las Vegas, NV 89120
• Contact: Jeff S Schleuning
• Correspondent: Jeff S Schleuning; BIODERMIS CORP. 3078 EAST SUNSET RD. SUITE #1 Las Vegas, NV 89120
• Product Code: MDA
• CFR Regulation Number: 878.4025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-06-24
• Decision Date: 1999-07-30

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850014883171	K992146	000
00854763005129	K992146	000
00854763005136	K992146	000
00854763005143	K992146	000
00854763005150	K992146	000
00854763005167	K992146	000
00854763005174	K992146	000
00854763005181	K992146	000
00854763005198	K992146	000
00854763005204	K992146	000
00854763005259	K992146	000
00854763005266	K992146	000
00854763005112	K992146	000
00854763005105	K992146	000
00854763005099	K992146	000
00850014883188	K992146	000
00850014883195	K992146	000
00850014883201	K992146	000
00854763005013	K992146	000
00854763005020	K992146	000
00854763005037	K992146	000
00854763005044	K992146	000
00854763005051	K992146	000
00854763005068	K992146	000
00854763005075	K992146	000
00854763005082	K992146	000
00854763005556	K992146	000
00854763005563	K992146	000
00854763005723	K992146	000
00854763005730	K992146	000
00854763005747	K992146	000
00854763005884	K992146	000
00854763005891	K992146	000
00854763005907	K992146	000
00854763005914	K992146	000
00854763005921	K992146	000
00854763005938	K992146	000
00854763005945	K992146	000
00854763005969	K992146	000
00854763005716	K992146	000
00854763005709	K992146	000
00854763005693	K992146	000
00854763005587	K992146	000
00854763005594	K992146	000
00854763005600	K992146	000
00854763005617	K992146	000
00854763005624	K992146	000
00854763005631	K992146	000
00854763005648	K992146	000
00854763005655	K992146	000
00854763005662	K992146	000
00854763005679	K992146	000
00854763005686	K992146	000
00854763005976	K992146	000