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#
- 3012680643
- 3027617478
- 3007735241
- 3015140210
- 3030017177
- 3027341451
- 3004018264
- 3004799623
- 3015337116
- 3014146451
- 3042251637
- 3012034017
- 1000317571
- 3017210336
- 3013034812
- 3015335956
- 3009548473
- 3015172365
- 1220246
- 3013671177
- 3008258694
- 3045325156
- 3014266447
- 3017896419
- 3011529314
- 3031841433
- 3025413691
- 1038758
- 3014848316
- 3011675351
- 3008255748
- 3003887292
- 3011248038
- 3015168783
- 3012502601
- 3027605322
- 3038284048
- 3016837630
- 3031582449
- 3038356900
- 1423537
- 1219592
- 3015142802
- 3010392991
- 3011247798
- 3005343641
- 3015745029
- 3021282544
- 3027517726
- 3012084379
- 3016170587
- 3015821396
- 3007841320
- 3010814025
- 3013524663
- 3008562678
- 3015142721
- 3032911850
- 3008384335
- 3026331889
- 3011210302
- 3014897003
- 3006611176
- 9616679
- 3018101380
- 3007028032
- 3008808560
- 3007417776
- 3013530949
- 3010952189
- 3010872396
- 3013496867
- 1250045
- 1320894
- 3031092085
- 3042205143
- 3017390965
- 9681544
- 2435947
- 3010018659
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