510(k) K843206
- Device
- COOK COUNTY HOSPITAL DRESSING CHANGE SET
- Applicant
- GENEVA LABORATORIES, INC.
- 510(k) number
- K843206
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-05-24
- Date received
- 1984-08-15
- 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
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 1222773
- 3014615028
- 1035236
- 3008132398
- 1048735
- 2648666
- 1047843
- 3013298431
- 3011499367
- 1721504
- 3001084743
- 3009746061
- 1319639
- 3031180770
- 9681465
- 3008676146
- 3010060157
- 3010452421
- 3009189869
- 3013002167
- 3002834291
- 3010531069
- 3013466775
- 1526611
- 3016068274
- 1223004
- 3021332749
- 3012478585
- 3003807268
- 3044571218
- 1643817
- 2011068
- 3006633581
- 9613083
- 3004892425
- 3004941127
- 2649614
- 3014257280
- 3008338766
- 3025603301
- 2024311
- 3007597038
- 1820334
- 3004638532
- 3010667733
- 3005273623
- 3008627763
- 3020468145
- 1928237
- 3008258694
- 3009513193
- 3010131137
- 3018094310
- 3010610950
- 3007329020
- 3019798849
- 1038671
- 3011707784
- 8020785
- 1000614268
- 3003960560
- 1417592
- 8030607
- 3008467060
- 3042158827
- 1061124
- 3004513970
- 1055236
- 1313525
- 3030681106
- 3004111573
- 3012130008
- 3005595283
- 3006128100
- 3011280379
- 1824619
- 3006098219
- 3033589330
- 3010052483
- 3030067857
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