Medline Collagen Wound Dressing
FDA 510(k) K060456 · Medline Industries, Inc.
510(k) numberK060456
Submission
- Device name
- Medline Collagen Wound Dressing
- Applicant
- Medline Industries, Inc.
Mundelein, IL, US - Received
- February 22, 2006
- Decision date
- June 19, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KGN – Wound Dressing With Animal-Derived Material(S)
- Device class
- Unclassified
- Implant
- Yes
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Questions and answers
When was Medline Collagen Wound Dressing cleared by the FDA?
Medline Collagen Wound Dressing (K060456) received a 510(k) decision of Substantially Equivalent on June 19, 2006, 117 days after the submission was received.
What is the product code of K060456?
The FDA product code is KGN – Wound Dressing With Animal-Derived Material(S), a Unclassified device.