Dumex Pak-Its-Absorbasalt Cotton Gauze Packing
FDA 510(k) K980777 · Dumex Medical Surgical Products, Ltd.
510(k) numberK980777
Submission
- Device name
- Dumex Pak-Its-Absorbasalt Cotton Gauze Packing
- Applicant
- Dumex Medical Surgical Products, Ltd.
Toronto, Orntario, CA - Received
- March 2, 1998
- Decision date
- May 4, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FRO – Dressing, Wound, Drug
- Device class
- Unclassified
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| K252023 | MiraChlor Antimicrobial Wound SolutionFRO · Traditional | Letus Corporation | 03/25/2026SE |
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More from Solventum Germany GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K992732 | Sterile Water & Sterile 0.9% Sodium ChlorideFOZ · Traditional | 04/20/2000SE |
| K993119 | Sterile HydrogelMGQ · Traditional | 11/23/1999SE |
| K990332 | Dumex Iodoform Packing StripFRO · Traditional | 04/14/1999SN |
| K980779 | Thalafix Natural Sea Salt DressingKMF · Traditional | 06/26/1998SN |
| K980861 | Dumex Pak-Its Cotton Gauze Packing Impregnated with HydrogelMGQ · Traditional | 05/20/1998SE |
| K980863 | Dumex Pak-Its Non-Woven Dressing Impregnated Sith Sodium Chloride (Hypertonic)KMF · Traditional | 05/11/1998SE |
| K980791 | Dumex Pak-Its Woven Ribbon PackingEFQ · Traditional | 04/29/1998SE |
| K960815 | Dupad, Dupad W/Abdom. Pad, Dumex Abdom. Pad, Combo Dressing Roll/Combine Dressing RollNAD · Traditional | 04/29/1996SE |
| K950132 | Dumex Wet DressingsFRO · Traditional | 03/01/1995SN |
| K946326 | Dutex Gauze BandageEFQ · Traditional | 01/24/1995SE |
Questions and answers
When was Dumex Pak-Its-Absorbasalt Cotton Gauze Packing cleared by the FDA?
Dumex Pak-Its-Absorbasalt Cotton Gauze Packing (K980777) received a 510(k) decision of Substantially Equivalent on May 4, 1998, 63 days after the submission was received.
What is the product code of K980777?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.