Non Adherent Bandage/Sheet
FDA 510(k) K833730 · American Medical Disposable, Inc.
510(k) numberK833730
Submission
- Device name
- Non Adherent Bandage/Sheet
- Applicant
- American Medical Disposable, Inc.
Mchenry, IL, US - Received
- October 25, 1983
- Decision date
- January 27, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FRO – Dressing, Wound, Drug
- Device class
- Unclassified
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| K254191 | IWD-GelFRO · Traditional | InnovaCorium, Inc. | 04/07/2026SE |
| K252023 | MiraChlor Antimicrobial Wound SolutionFRO · Traditional | Letus Corporation | 03/25/2026SE |
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More from Solventum Germany GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K833735 | An Odor Absorbent BandageNAB · Traditional | 04/23/1984SE |
| K833734 | Neurological Sponge on Plastic Stick · Traditional | 04/23/1984SE |
| K833731 | Breathable Overwray Bandage Non-ElasKGX · Traditional | 01/27/1984SE |
| K833729 | Elastic Breathable Over-Wrap BandageNAD · Traditional | 12/30/1983SE |
| K833733 | Non - Adherent BandageFRO · Traditional | 12/27/1983SE |
| K833732 | Non Wetting Undercast PaddingITG · Traditional | 12/12/1983SE |
| K830202 | Cotton Balls, X-Ray Opaqued Strung & NonGDY · Traditional | 02/23/1983SE |
| K830201 | Polyester X-Ray Detectable Strung-SpongeGDY · Traditional | 02/23/1983SE |
| K803116 | Heavy Drainage PackGEC · Traditional | 01/28/1981SE |
| K803115 | Dressing Change for G TubeFRO · Traditional | 01/06/1981SE |
Questions and answers
When was Non Adherent Bandage/Sheet cleared by the FDA?
Non Adherent Bandage/Sheet (K833730) received a 510(k) decision of Substantially Equivalent on January 27, 1984, 94 days after the submission was received.
What is the product code of K833730?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.