Aquaphor R Gauze
FDA 510(k) K842967 · Beiersdorf, Inc.
510(k) numberK842967
Submission
- Device name
- Aquaphor R Gauze
- Applicant
- Beiersdorf, Inc.
Norwalk, CT, US - Received
- July 27, 1984
- Decision date
- November 8, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FRO – Dressing, Wound, Drug
- Device class
- Unclassified
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| K032462 | Curad Silver Active Gel BandageFRO · Traditional | 02/10/2004SE |
| K024057 | Curad Scar TherapyMDA · Traditional | 06/18/2003SE |
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| 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 Aquaphor R Gauze cleared by the FDA?
Aquaphor R Gauze (K842967) received a 510(k) decision of Substantially Equivalent on November 8, 1984, 104 days after the submission was received.
What is the product code of K842967?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.