Silver Antimicrobial Wound Gauze (Sponge)
FDA 510(k) K042164 · Medline Industries, Inc.
510(k) numberK042164
Submission
- Device name
- Silver Antimicrobial Wound Gauze (Sponge)
- Applicant
- Medline Industries, Inc.
Portland, OR, US - Received
- August 11, 2004
- Decision date
- June 9, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRO – Dressing, Wound, Drug
- Device class
- Unclassified
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Questions and answers
When was Silver Antimicrobial Wound Gauze (Sponge) cleared by the FDA?
Silver Antimicrobial Wound Gauze (Sponge) (K042164) received a 510(k) decision of Substantially Equivalent on June 9, 2005, 302 days after the submission was received.
What is the product code of K042164?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.