510(k) K861972
- Device
- DERMISTRIP
- Applicant
- KELLS MEDICAL, INC.
- 510(k) number
- K861972
- Product code
- FRO
- Decision
- Substantially Equivalent For Some Indications (SN)
- Decision date
- 1986-06-27
- Date received
- 1986-05-21
- 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#
- Contact
- JOHN SWEENEY
- Address
- 136 Shore Dr. Burr Ridge IL US 60521 60521
FDA Registration Numbers#
- 3008806809
- 3000210785
- 1926681
- 3032911850
- 3035523371
- 1038963
- 1287317
- 3015745029
- 3016920640
- 3008044603
- 3004681519
- 1720929
- 3004135030
- 3016758972
- 3014195785
- 3012680643
- 2135339
- 3010305275
- 3009486864
- 3003799320
- 3016615875
- 3041329419
- 9680357
- 3031582449
- 3005113244
- 3026263452
- 3010621964
- 1018233
- 1060680
- 3023191945
- 3006517436
- 3030333982
- 3007327603
- 3023316
- 3010763707
- 3044466317
- 1648579
- 3007607706
- 3014312726
- 3008132398
- 2530957
- 3002468342
- 3012084379
- 3017036472
- 3039775399
- 3041276890
- 3008485841
- 3015134081
- 3033520596
- 3015937050
- 3008374791
- 3031582434
- 3030394731
- 1420763
- 3023141635
- 3007125968
- 3021013122
- 3005619478
- 3010610950
- 3005761322
- 3008496560
- 3042953785
- 3030067857
- 8010803
- 2648727
- 3016096140
- 3021082429
- 3011715922
- 3037031822
- 3027977504
- 3007735241
- 3043503913
- 3010824458
- 3009931872
- 3004857344
- 3010160527
- 3018101380
- 1000317571
- 3007282994
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