Cutinova(R) Plus on Vascular Stasis Ulcers
FDA 510(k) K885279 · Beiersdorf, Inc.
510(k) numberK885279
Submission
- Device name
- Cutinova(R) Plus on Vascular Stasis Ulcers
- Applicant
- Beiersdorf, Inc.
Norwalk, CT, US - Received
- December 23, 1988
- Decision date
- June 13, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FRO – Dressing, Wound, Drug
- Device class
- Unclassified
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| K944581 | Cutinova Thin Wound DressingKMF · Traditional | 12/02/1994SN |
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Questions and answers
When was Cutinova(R) Plus on Vascular Stasis Ulcers cleared by the FDA?
Cutinova(R) Plus on Vascular Stasis Ulcers (K885279) received a 510(k) decision of Substantially Equivalent on June 13, 1989, 172 days after the submission was received.
What is the product code of K885279?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.