510(k) K802793
- Device
- LOMATUELL OINTMENT DRESSING
- Applicant
- SECOL CO.
- 510(k) number
- K802793
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-12-18
- Date received
- 1980-11-04
- 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#
- 3010700223
- 3012940386
- 3008261762
- 3016807311
- 3014570707
- 3008806809
- 3016746332
- 1250045
- 3013557562
- 3012852163
- 3016170587
- 3038356900
- 9680091
- 2518467
- 3021282544
- 3032911850
- 3008646686
- 3006784948
- 3015745029
- 3031841433
- 3007124979
- 3010035774
- 3010934856
- 3008044603
- 3007187674
- 3008562678
- 3038310422
- 3004957256
- 3008427684
- 1219103
- 3004799623
- 2218158
- 3016758972
- 3009134882
- 1417592
- 3012777736
- 3013226
- 3015337116
- 3004018264
- 3003676119
- 3015414875
- 3010872396
- 1423537
- 3012680643
- 3030017177
- 3005621729
- 3038624837
- 3035641077
- 3017297225
- 3012311599
- 3042272797
- 2110420
- 3010155661
- 3013530901
- 3006358042
- 3011814545
- 3016615875
- 3007327621
- 3041329419
- 3010018659
- 3015142721
- 3031582449
- 2954718
- 9614157
- 3003866267
- 3026263452
- 3008174904
- 3023339256
- 3044150131
- 3017930281
- 3013632692
- 3012907824
- 3038284048
- 3006517436
- 9680731
- 3013957847
- 9616679
- 3003175285
- 3008693666
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#
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
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