510(k) K080524
- Device
- CENTURION SORBAVIEW OTC
- Applicant
- TRI-STATE HOSPITAL SUPPLY CORP.
- 510(k) number
- K080524
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-04-23
- Date received
- 2008-02-26
- Regulation
- 510(k) Premarket Notification
- Classification name
- Dressing, Wound, Drug
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MATTHEW K PRICE
- Address
- 301 Catrell Dr. Howell MI US 48843 48843
FDA Registration Numbers#
- 3007417776
- 1648579
- 3006517436
- 3030446844
- 3033451996
- 3016009624
- 3012026312
- 3006082230
- 3016159364
- 3016674858
- 3010374920
- 3015414875
- 3025430561
- 2122594
- 3015378469
- 3017297225
- 3023855650
- 3015515018
- 2953359
- 2951555
- 1643817
- 3004022422
- 3003965134
- 3002807090
- 3005460813
- 1018120
- 3013525704
- 3008392711
- 9680794
- 3007307589
- 3017390965
- 3045058049
- 3044777107
- 3013526501
- 1034876
- 3012090726
- 3014146451
- 3011280379
- 3017396949
- 3012809732
- 3017448136
- 3008044603
- 1047843
- 1000118068
- 3013530949
- 3023141635
- 3000268902
- 9710603
- 3009562494
- 3010273867
- 3010160527
- 3036035308
- 3017417635
- 3048248080
- 3009109670
- 3017930281
- 3030421258
- 3017036472
- 2435947
- 2110898
- 3013154850
- 3004869142
- 3018101380
- 3045076483
- 3012421607
- 3037918935
- 1423537
- 3008808082
- 3038274448
- 9680357
- 1287317
- 3013354376
- 3016615875
- 3015946389
- 3013517171
- 2135152
- 3011715978
- 3006633581
- 3034618336
Source Documents#
Other 510(k) Records For Product Code FRO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254168 | Actolind® (06.3637. Actolind® Gel Plus) | ACTO GmbH | 2026-09-22 |
| K254041 | SkinSmart Antimicrobial HydroGel | Magic Science Supply, LLC | 2026-09-11 |
| K261646 | Redermax® Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | 2026-08-14 |
| K253665 | Vashe Plus Antimicrobial Solution | Urgo Medical North America, LLC | 2026-08-11 |
| K251929 | SilverCeuticals® Antimicrobial Wound Gel | Silverceuticals, Inc. | 2026-06-24 |
| K261023 | Microdacyn Wound Irrigation Solution | Sonoma Pharmaceuticals, Inc. | 2026-06-24 |
| K261638 | Bonvadis® | Oneness Biotech Co., Ltd. | 2026-06-17 |
| K254073 | StatSeal Disc | Merit Medical Systems, Inc. | 2026-05-13 |
| K254191 | IWD-Gel™ | InnovaCorium, Inc. | 2026-04-07 |
| K252023 | MiraChlor Antimicrobial Wound Solution | Letus Corporation | 2026-03-25 |
| K251999 | Promogran Prisma™ Collagen Matrix with ORC and Silver | Solventum Germany GmbH | 2026-03-13 |
| K252028 | LUOFUCON® Antimicrobial Wound Gel | Huizhou Foryou Medical Co., Ltd. | 2026-03-11 |
| K251582 | Redermax Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | 2026-02-02 |
| K252568 | New Day Skin Spray | Silk Holdings, Inc. | 2026-01-23 |
| K250890 | SBC1 Cream | Sioxmed, LLC | 2026-01-12 |
Legacy Summary#
summary
FDA Review#
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