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#
- 3014666579
- 3008656870
- 3022085015
- 3021013122
- 3008132398
- 3009109670
- 1048735
- 3006142527
- 1047843
- 3013298431
- 1000317571
- 3042953785
- 3005761322
- 3023855650
- 3007735241
- 3007307589
- 3044026004
- 3021228307
- 3008384548
- 1038758
- 3012309743
- 1420763
- 3008572121
- 3016445778
- 1319639
- 2320961
- 3017036472
- 9680143
- 3008676146
- 1930027
- 3012034017
- 3011191255
- 3010452421
- 3023141635
- 1038963
- 3027344214
- 8044178
- 3042972928
- 3012084379
- 3025413691
- 3012314549
- 3030088999
- 3017930281
- 3007648359
- 3003835287
- 1643817
- 3016096140
- 9611462
- 3006633581
- 1644312
- 9710020
- 3009057691
- 3011582224
- 3007327603
- 3008298053
- 3006802076
- 3015142802
- 3007048057
- 3008262278
- 3013034812
- 3016769192
- 3007966889
- 3005841027
- 3010339057
- 3015821396
- 3008258694
- 3010131137
- 3011248163
- 3010610950
- 3010155648
- 3005113244
- 3010419931
- 3007594734
- 3032812695
- 3015174114
- 3015456954
- 3043041704
- 3027517726
- 3007605720
Source Documents#
Other 510(k) Records For Product Code FRO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K252759 | revyve® Antimicrobial Skin and Wound Cleanser | Kane Biotech, Inc. | 2026-01-08 |
| K251757 | Puracyn® Plus Antimicrobial Irrigation Solution | Innovacyn, Inc. | 2026-01-05 |
| K252167 | Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) | Qingdao Bright Moon Biomedical Materials Co., Ltd. | 2025-12-19 |
| K250642 | LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) | Huizhou Foryou Medical Devices Co., Ltd. | 2025-11-19 |
Legacy Summary#
summary
FDA Review#
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