Cutinova(R) Plus Foam Gelfilm
FDA 510(k) K864913 · Beiersdorf, Inc.
510(k) numberK864913
Submission
- Device name
- Cutinova(R) Plus Foam Gelfilm
- Applicant
- Beiersdorf, Inc.
Norwalk, CT, US - Received
- December 16, 1986
- Decision date
- July 24, 1987
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- FRO – Dressing, Wound, Drug
- Device class
- Unclassified
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| 510(k) | Device | Decision |
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| K032463 | Curad Silver BandageFRO · Traditional | 02/10/2004SE |
| K032462 | Curad Silver Active Gel BandageFRO · Traditional | 02/10/2004SE |
| K024057 | Curad Scar TherapyMDA · Traditional | 06/18/2003SE |
| K022645 | CuradKMF · Traditional | 11/05/2002SE |
| K952526 | Cutinova CavityKMF · Traditional | 08/14/1995SN |
| K943363 | Cutiplast SterilMGP · Traditional | 03/15/1995SE |
| K944581 | Cutinova Thin Wound DressingKMF · Traditional | 12/02/1994SN |
| K935630 | NortaEZL · Traditional | 10/07/1994SE |
| K940378 | Coverlet Adhesive DressingKGX · Traditional | 07/29/1994SN |
Questions and answers
When was Cutinova(R) Plus Foam Gelfilm cleared by the FDA?
Cutinova(R) Plus Foam Gelfilm (K864913) received a 510(k) decision of Substantially Equivalent for Some Indications on July 24, 1987, 220 days after the submission was received.
What is the product code of K864913?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.