Nu-Gel * Wound Dressing
FDA 510(k) K983362 · Johnson & Johnson Medical, Inc.
510(k) numberK983362
Submission
- Device name
- Nu-Gel * Wound Dressing
- Applicant
- Johnson & Johnson Medical, Inc.
Arlington, TX, US - Received
- September 24, 1998
- Decision date
- December 16, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MGQ – Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
- Device class
- Unclassified
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| K041342 | Impruv A.I. Cream Wound and Skin EmulsionMGQ · Traditional | Stiefel Laboratories, Inc. | 07/19/2005SE |
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| K024367 | Sinclair Wound and Skin EmulsionMGQ · Traditional | Sinclair Pharmaceuticals, Ltd. | 07/28/2003SE |
| K024054 | Xylos Xcell Antimicrobial DressingMGQ · Traditional | Xylos Corporation | 03/07/2003SE |
| K022584 | Cardiotech Antibotic Hydrogel Wound DressingMGQ · Traditional | Cardiotech Intl. | 12/30/2002SE |
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| K014129 | Promogran Matrix Wound DressingKGN · Traditional | 02/14/2002SE |
| K001690 | Protectiv Safety Blood Collection NeedleFMI · Traditional | 07/31/2000SE |
| K982641 | Advanced Nibp ModuleDXN · Traditional | 03/29/1999SE |
| K982597 | Fibrcol Plus Collagen Wound Dressing with AlginateKGN · Traditional | 08/20/1998SE |
| K974080 | Critikon Soft Blood Pressure CuffDXQ · Traditional | 05/18/1998SE |
| K980493 | I.V. Catheter SystemFOZ · Traditional | 04/28/1998SE |
| K972498 | Observer * Central StationDSI · Traditional | 02/17/1998SE |
| K973699 | Ultralon Powder Free Latex Surgical GloveKGO · Traditional | 12/16/1997SE |
Questions and answers
When was Nu-Gel * Wound Dressing cleared by the FDA?
Nu-Gel * Wound Dressing (K983362) received a 510(k) decision of Substantially Equivalent on December 16, 1998, 83 days after the submission was received.
What is the product code of K983362?
The FDA product code is MGQ – Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic, a Unclassified device.