510(k) K874480
- Device
- MODIFIED MANUFACTURING PROCESS FOR OMIDERM(TM)
- Applicant
- OMIKRON SCIENTIFIC, LTD.
- 510(k) number
- K874480
- Product code
- FRO
- Decision
- Substantially Equivalent For Some Indications (SN)
- Decision date
- 1988-02-22
- Date received
- 1987-11-02
- 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
- MARC COLES
- Address
- Kiryat Weizmann P.O.B. 2012, Rehovot 76120 Israel IL
FDA Registration Numbers#
- 1123137
- 3022568093
- 3017846547
- 3015821396
- 3042277868
- 3035767957
- 3009057691
- 3015414875
- 3018507299
- 1060680
- 3016159364
- 3011582224
- 3005034064
- 9611024
- 3004022422
- 3026331889
- 3006802076
- 3010131137
- 2939142
- 3004102812
- 3030087693
- 3013122778
- 3005735974
- 1043549
- 3004270595
- 3042283853
- 1930027
- 3007187674
- 1287317
- 3003965134
- 3003636207
- 3032327991
- 2530957
- 3009039068
- 2183416
- 3029971427
- 3017036472
- 3005858760
- 3011191255
- 9610694
- 3017396949
- 3012441818
- 3015341499
- 3038988287
- 3021082429
- 3015058854
- 9710608
- 3003835287
- 3015140210
- 1720929
- 3009486864
- 3011715978
- 1034876
- 3015781786
- 3010546717
- 3013354376
- 3010165567
- 3009562494
- 3025771169
- 3013557562
- 3011689956
- 3034604687
- 3023339256
- 3009109670
- 1119193
- 1000119796
- 3004857344
- 3014747754
- 1417592
- 1018120
- 3009882464
- 3008392711
- 3023191945
- 3009640188
- 3013510154
- 9680198
- 1038963
- 3006371704
- 3039775399
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FRO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K250115 | Hemastyl(™) Wound Dressing | Rapid Nexus Nanotech Wound Solutions, Inc. | 2025-10-14 |
| K251866 | Tegaderm Post-Op Transparent Antimicrobial Dressing | Solventum US, LLC | 2025-10-10 |
| K243166 | Dermalage | Infection Elimination Solutions, LLC | 2025-08-27 |
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