Dressing Change for G Tube
FDA 510(k) K803115 · American Medical Disposable, Inc.
510(k) numberK803115
Submission
- Device name
- Dressing Change for G Tube
- Applicant
- American Medical Disposable, Inc.
Mchenry, IL, US - Received
- December 10, 1980
- Decision date
- January 6, 1981
- Decision
- Substantially Equivalent (SESE)
- 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 |
|---|---|---|
| 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 |
| K833730 | Non Adherent Bandage/SheetFRO · 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 |
Questions and answers
When was Dressing Change for G Tube cleared by the FDA?
Dressing Change for G Tube (K803115) received a 510(k) decision of Substantially Equivalent on January 6, 1981, 27 days after the submission was received.
What is the product code of K803115?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.