510(k) K905519
- Device
- MONTROSE DRESSING APPLICATORS
- Applicant
- OLEMUNDA PTY LTD.
- 510(k) number
- K905519
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-03-06
- Date received
- 1990-12-07
- 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
- HANIA CLEVA
- Address
- One Landmark N. 20399 Rte. 19 Evans City PA US 16033 16033
FDA Registration Numbers#
- 3004869142
- 3026263452
- 3009080375
- 3007307589
- 3044150131
- 3014368824
- 3017930281
- 1629057
- 3007007790
- 3039775399
- 3003887292
- 3008076203
- 1646434
- 3013557562
- 9710583
- 3011280379
- 3023809973
- 3006082230
- 3030088999
- 3004547763
- 8044178
- 3015515018
- 3042283853
- 3008384548
- 3013122778
- 3008044603
- 3012026312
- 3013517086
- 1423662
- 9611462
- 3013034812
- 3029875292
- 9614157
- 3008427684
- 3006506075
- 3025430795
- 3015456954
- 3038200636
- 3009931872
- 3016901080
- 3016515429
- 3041276890
- 3013154850
- 3004713654
- 3002807090
- 3017448136
- 3025430561
- 3015134081
- 3035523371
- 3013298431
- 3013354376
- 3009167225
- 3003403221
- 3013526501
- 9680357
- 3017846547
- 3008298053
- 3021228307
- 3042206168
- 3015416207
- 3029995180
- 3003799320
- 3045076483
- 3017264244
- 3042972928
- 3033520596
- 3010178296
- 3017911878
- 3016450032
- 3034669683
- 3003559457
- 3023339256
- 3007125336
- 3010160370
- 1287317
- 3015378469
- 9680091
- 3015058854
- 1018233
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FRO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K251757 | Puracyn® Plus Antimicrobial Irrigation Solution | Innovacyn, Inc. | 2026-01-05 |
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