510(k) K960815
- Device
- DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSING ROLL
- Applicant
- DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
- 510(k) number
- K960815
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-04-29
- Date received
- 1996-02-28
- 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
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANGELO GUERRIERO
- Address
- 104 Shorting Rd. Toronto, Orntario CA M1S 3S4 M1S 3S4
FDA Registration Numbers#
- 3004869142
- 3004022422
- 1648579
- 9616572
- 3013510154
- 1424263
- 3003403221
- 3039435289
- 3005619478
- 3030226294
- 3030446844
- 1925025
- 3015416207
- 3006142527
- 3030017177
- 9617592
- 3006065092
- 1926681
- 3007282994
- 3003807757
- 3010178296
- 3017846547
- 3005858760
- 3013354376
- 9680198
- 3006517436
- 3044466317
- 3016758972
- 2031094
- 3008242042
- 3008102042
- 3009640188
- 3011689956
- 3029995180
- 3008298053
- 9615662
- 3014437893
- 3014579161
- 3011280379
- 3008951115
- 3026331889
- 3008258694
- 3042261316
- 1319639
- 3027344214
- 3008824097
- 9611024
- 3006405073
- 3038988287
- 3008076203
- 3021013122
- 1480288
- 3004080548
- 3009504230
- 3034604687
- 3010374920
- 3010273867
- 3016674858
- 3008496560
- 3017448136
- 3035786168
- 1055236
- 3011210302
- 3011307048
- 3045857302
- 1720929
- 3009057691
- 1037885
- 3003559457
- 3010165567
- 3035767957
- 3034669683
- 1423537
- 3025771169
- 3004950768
- 3010339057
- 3005735974
- 3008427684
- 3012777736
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FRO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261023 | Microdacyn Wound Irrigation Solution | Sonoma Pharmaceuticals, Inc. | 2026-06-24 |
| K251929 | SilverCeuticals® Antimicrobial Wound Gel | Silverceuticals, 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