Product code NAC
- Device name
- Dressing, Wound, Hydrophilic
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4018
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K082208 | DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER | Scivolutions, Inc. | 2008-12-01 |
| K925841 | HYDRASORB JOYCE SPONGE | Avitar, Inc. | 1993-05-12 |
| K914575 | SORBSAN TOPICAL WOUND DRESSING (MODIFIED) | Dow B. Hickam, Inc. | 1991-12-04 |
| K914779 | ALGINATE FIBER | Adri/Technam | 1991-12-04 |
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| 00810178889945 | ViveCare | VIVE HEALTH LLC | 2026-05-29 |
| 00850087488433 | Ceeport | CEEPORT INC. | 2026-05-29 |
| 00850087488440 | Ceeport | CEEPORT INC. | 2026-05-29 |
| 00850087488518 | Ceeport | CEEPORT INC. | 2026-05-29 |
| 00324357410153 | Zeni Medical | Focus Health Group, Inc. | 2026-04-13 |
| 00324357600448 | Zeni Medical | Focus Health Group, Inc. | 2026-04-13 |
| 00324357410160 | Zeni Medical | Focus Health Group, Inc. | 2026-04-13 |
| 00324357410146 | Zeni Medical | Focus Health Group, Inc. | 2026-04-13 |
| 00324357410139 | Zeni Medical | Focus Health Group, Inc. | 2026-04-13 |
| 00324357410122 | Zeni Medical | Focus Health Group, Inc. | 2026-04-13 |
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| 00324357410108 | Zeni Medical | Focus Health Group, Inc. | 2026-04-13 |
| 00324357410092 | Zeni Medical | Focus Health Group, Inc. | 2026-04-13 |
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| 00361554003818 | Gentell | Gentell, LLC | 2024-11-29 |
| 00361554003870 | Gentell | Gentell, LLC | 2024-11-29 |
| 00324357600882 | Zeni Medical | Focus Health Group, Inc. | 2023-05-31 |
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| 08711428064650 | 3M™ Tegaderm™ | 3M COMPANY | 2018-09-24 |
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| 08711428077452 | 3M™ Tegaderm™ | 3M COMPANY | 2018-09-24 |