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#
- 3011715978
- 3003799320
- 3010305275
- 3012034017
- 3034669683
- 1000317571
- 3013034812
- 1047843
- 3011862887
- 1038758
- 3003835287
- 3017235663
- 9680143
- 3030333982
- 3019804885
- 3014421917
- 3021282544
- 3005735974
- 3009039068
- 3010785927
- 3008264111
- 3007417776
- 3012441818
- 2951555
- 3009167225
- 3030067857
- 1055236
- 3012777736
- 3010034780
- 3007307589
- 3005841027
- 2135152
- 3035523371
- 3011582224
- 3008958609
- 3015276780
- 9614157
- 3017264244
- 3003965134
- 9616872
- 3010824458
- 3010512490
- 3044777107
- 3008076203
- 1644312
- 3011307048
- 3021630959
- 3038200636
- 9710020
- 9616088
- 1018233
- 1054241
- 3006371704
- 3004022422
- 3005460813
- 1043549
- 1420763
- 3008485841
- 3007966889
- 1319639
- 3005858760
- 3008676146
- 3017846547
- 3002807310
- 3011089435
- 3004869142
- 3003807757
- 3011707784
- 3009171251
- 3008502431
- 8010485
- 3014368824
- 3034605486
- 3025430561
- 3006358042
- 1000118068
- 3044026004
- 2135339
- 3018116884
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