510(k) K897142
- Device
- MESALT STERILE DRESSING
- Applicant
- SCOTT HEALTH CARE
- 510(k) number
- K897142
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-03-27
- Date received
- 1989-12-27
- 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
- U
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD A HAMER
- Address
- Scott Plz. Iii Philadelphia PA US 19113 19113
FDA Registration Numbers#
- 3015282703
- 1000317571
- 2245304
- 1047843
- 3011862887
- 1038758
- 9680143
- 3005706359
- 3014421917
- 3006498370
- 3008562678
- 2083373
- 3012448339
- 3005818605
- 3016116741
- 3009167225
- 3030067857
- 1055236
- 1222747
- 3010034780
- 3036978602
- 2135152
- 1319660
- 3015276780
- 3015309358
- 3024856793
- 9614157
- 2031987
- 3015422337
- 3010824458
- 3004637474
- 2124143
- 3038624837
- 3013478891
- 3014635301
- 3003477135
- 2032098
- 1417519
- 9616088
- 1054241
- 1650927
- 3005460813
- 1043549
- 3007966889
- 3000215556
- 3002807310
- 8030128
- 3011089435
- 3002636527
- 3009750086
- 3009171251
- 3008502431
- 3010131578
- 3013035118
- 3010315629
- 3004170064
- 3044026004
- 1064858
- 1649690
- 2135339
- 1417592
- 3037918935
- 3007605720
- 3003636207
- 3042366049
- 3010363503
- 3015077448
- 3002807315
- 1061124
- 3006506075
- 3008132238
- 3009655869
- 3010452421
- 3018167761
- 3018153007
- 3023113877
- 3007007790
- 3005533873
- 3004681519
Source Documents#
510(k) summary PDF not indicated by FDA
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#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases