EPI-DERM 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 Epi-derm Silicone Gel Sheeting.

Pre-market Notification Details

• Device ID: K003948
• 510k Number: K003948
• Device Name: EPI-DERM 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 Schleuing
• Correspondent: Jeff S Schleuing; 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: 2000-12-21
• Decision Date: 2001-01-29

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00852260000494	K003948	000
00852260000333	K003948	000
00852260000326	K003948	000
00852260000319	K003948	000
00852260000302	K003948	000
00852260000296	K003948	000
00852260000289	K003948	000
00852260000272	K003948	000
00852260000265	K003948	000
00852260000258	K003948	000
00852260000241	K003948	000
00852260000234	K003948	000
00852260000340	K003948	000
00852260000357	K003948	000
00852260000364	K003948	000
00852260000487	K003948	000
00852260000470	K003948	000
00852260000463	K003948	000
00852260000456	K003948	000
00852260000449	K003948	000
00852260000425	K003948	000
00852260000418	K003948	000
00852260000401	K003948	000
00852260000395	K003948	000
00852260000388	K003948	000
00852260000371	K003948	000
00852260000227	K003948	000
00852260000210	K003948	000
00852260000203	K003948	000
00852260000029	K003948	000
00852260000012	K003948	000
00850014883065	K003948	000
00850014883058	K003948	000
00850014883041	K003948	000
00850014883034	K003948	000
00850014883027	K003948	000
00850014883010	K003948	000
00372380000322	K003948	000
00372380000315	K003948	000
00372380000384	K003948	000
00852260000036	K003948	000
00852260000043	K003948	000
00852260000067	K003948	000
00852260000197	K003948	000
00852260000180	K003948	000
00852260000173	K003948	000
00852260000166	K003948	000
00852260000159	K003948	000
00852260000128	K003948	000
00852260000111	K003948	000
00852260000104	K003948	000
00852260000098	K003948	000
00852260000081	K003948	000
00852260000074	K003948	000
10372380000008	K003948	000
00852260000500	K003948	000
00372380000032	K003948	000
00852260000920	K003948	000
00852260000913	K003948	000
00852260000906	K003948	000
00852260000890	K003948	000
00852260000876	K003948	000
00852260000852	K003948	000
00852260000845	K003948	000
00852260000838	K003948	000
00852260000821	K003948	000
00852260000814	K003948	000
00852260000807	K003948	000
00852260000937	K003948	000
00852260000944	K003948	000
00852260000951	K003948	000
00372380000025	K003948	000
00372380000018	K003948	000
00854763005877	K003948	000
00854763005860	K003948	000
00854763005501	K003948	000
00854763005495	K003948	000
00854763005242	K003948	000
00854763005235	K003948	000
00854763005006	K003948	000
00852260000999	K003948	000
00852260000968	K003948	000
00852260000791	K003948	000
00852260000784	K003948	000
00852260000777	K003948	000
00852260000623	K003948	000
00852260000616	K003948	000
00852260000609	K003948	000
00852260000593	K003948	000
00852260000586	K003948	000
00852260000579	K003948	000
00852260000562	K003948	000
00852260000555	K003948	000
00852260000548	K003948	000
00852260000531	K003948	000
00852260000524	K003948	000
00852260000630	K003948	000
00852260000647	K003948	000
00852260000654	K003948	000
00852260000760	K003948	000
00852260000753	K003948	000
00852260000746	K003948	000
00852260000739	K003948	000
00852260000722	K003948	000
00852260000715	K003948	000
00852260000708	K003948	000
00852260000692	K003948	000
00852260000685	K003948	000
00852260000678	K003948	000
00852260000661	K003948	000
00852260000517	K003948	000