ELTA SILVER ANTIMICROBIAL WOUND GEL DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC

Dressing, Wound, Drug

SWISS AMERICAN PRODUCTS, INC.

The following data is part of a premarket notification filed by Swiss American Products, Inc. with the FDA for Elta Silver Antimicrobial Wound Gel Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic.

Pre-market Notification Details

• Device ID: K071703
• 510k Number: K071703
• Device Name: ELTA SILVER ANTIMICROBIAL WOUND GEL DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC
• Classification: Dressing, Wound, Drug
• Applicant: SWISS AMERICAN PRODUCTS, INC. 2055 LUNA RD., STE. 126 Carrollton, TX 75006
• Contact: Eric Luo
• Correspondent: Eric Luo; SWISS AMERICAN PRODUCTS, INC. 2055 LUNA RD., STE. 126 Carrollton, TX 75006
• 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: 2007-06-21
• Decision Date: 2007-08-22

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00390205025305	K071703	000
10090205025288	K071703	000
10090205025264	K071703	000
00827854009832	K071703	000