510(k) K810902
- Device
- IP-758 BURN WOUND DRESSING
- Applicant
- EXOPACK
- 510(k) number
- K810902
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-09-11
- Date received
- 1981-04-03
- 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
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3038220293
- 3008261762
- 9681544
- 1644312
- 3025430795
- 1219103
- 3008384335
- 1526534
- 3008255748
- 3027517726
- 1063707
- 1038758
- 3011675351
- 1121142
- 3007028032
- 3016450032
- 3009655869
- 3006358042
- 3012680643
- 3012314549
- 3010034780
- 3010392991
- 3008693666
- 1250045
- 3018101380
- 3014312726
- 3012940386
- 3031092085
- 9616679
- 3007607706
- 3010198795
- 3026263452
- 3020978033
- 3021841055
- 8044178
- 3010256218
- 3006784948
- 2954718
- 3016758972
- 3043012215
- 3007327621
- 3044026004
- 3031841433
- 3006253843
- 3007124979
- 3043026391
- 3005034064
- 3030067857
- 3009167225
- 3011210302
- 3015414875
- 2212018
- 3045058049
- 3010288357
- 3015745029
- 1054811
- 3006611176
- 3010131715
- 3009548473
- 3009134882
- 3007187674
- 3030017177
- 3007841320
- 3015264433
- 3007145088
- 3038014307
- 1649518
- 3016807211
- 3008386507
- 3011247798
- 3041913476
- 3035641077
- 3016746332
- 3006788879
- 3011248038
- 3013957847
- 3015172365
- 3015142721
- 3009482034
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