510(k) K833075
- Device
- WET DRESSING KIT
- Applicant
- CLINIPAD CORP.
- 510(k) number
- K833075
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-01-27
- Date received
- 1983-09-09
- 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
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1221934
- 3010353405
- 3014383382
- 2431166
- 3013980229
- 2029275
- 3004111573
- 2648623
- 3004122598
- 3032747418
- 3017461134
- 3014644369
- 1836161
- 3013466775
- 3007139365
- 2032098
- 3017059795
- 3021006167
- 8030607
- 3008902714
- 3022320321
- 3032579548
- 3044571218
- 3004519921
- 3010583458
- 3016068274
- 1526611
- 3007007790
- 3012358417
- 3014457631
- 1061124
- 3003528228
- 1420054
- 3014615028
- 9680002
- 1055236
- 3015337348
- 3006617885
- 3010380518
- 3022132808
- 3005108347
- 3008676146
- 3042158827
- 3010131137
- 1423537
- 3008132398
- 2183744
- 3010060157
- 3008650117
- 9616872
- 3010155661
- 3013680140
- 1018470
- 3009888344
- 1000614268
- 2245304
- 3008559295
- 3010178296
- 3014421917
- 2953359
- 1223004
- 3017607477
- 3025603301
- 3008824097
- 1422598
- 1721686
- 1061927
- 3006542380
- 9617977
- 3014637079
- 3003807268
- 3045058049
- 9611024
- 3011089435
- 3004598675
- 2433012
- 1417592
- 3003960560
- 3005675811
- 3039169546
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FRO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K252759 | revyve® Antimicrobial Skin and Wound Cleanser | Kane Biotech, Inc. | 2026-01-08 |
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