Cutinova Gelfilm Synthetic Wound Dressing, Sterile
FDA 510(k) K850147 · Beiersdorf, Inc.
510(k) numberK850147
Submission
- Device name
- Cutinova Gelfilm Synthetic Wound Dressing, Sterile
- Applicant
- Beiersdorf, Inc.
Norwalk, CT, US - Received
- January 14, 1985
- Decision date
- July 5, 1985
- 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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More from Solventum Germany GmbH
| 510(k) | Device | Decision |
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| K090921 | Anti-Embolism Stockings, Models 71055-00000-02, 71057-00000-02, 71059-00000-02…DWL · Traditional | 12/18/2009SE |
| 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 Gelfilm Synthetic Wound Dressing, Sterile cleared by the FDA?
Cutinova Gelfilm Synthetic Wound Dressing, Sterile (K850147) received a 510(k) decision of Substantially Equivalent for Some Indications on July 5, 1985, 172 days after the submission was received.
What is the product code of K850147?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.