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#
- 3014848316
- 3030067857
- 3031092085
- 3014312726
- 2530957
- 3006611176
- 3013226
- 3015745029
- 3031582449
- 3008386507
- 3016837630
- 3011210302
- 3008562678
- 1223925
- 3006802076
- 3016615875
- 3042277868
- 3013671177
- 3039386251
- 3038356900
- 1649690
- 3005951403
- 2435947
- 3012084379
- 3012034017
- 3008244559
- 3023339256
- 3009134882
- 3017210336
- 9680731
- 2110420
- 3042251637
- 3042205143
- 3019315696
- 3044921221
- 3012711490
- 3010132111
- 2135152
- 3007124979
- 3010951382
- 3021389253
- 3011983031
- 3009540516
- 3017297225
- 3007417776
- 1063707
- 3008808082
- 3005613390
- 3006621348
- 3004957256
- 3026331889
- 3010256218
- 3013445151
- 3015264433
- 9710020
- 3044150131
- 3033536319
- 3017417635
- 3004448390
- 3027977504
- 3004530184
- 3045325156
- 1038758
- 3043012215
- 3015142721
- 3016807311
- 3017633586
- 3005621729
- 3027617478
- 3010198795
- 3014570707
- 3042972928
- 3008174904
- 3042158718
- 3009482034
- 3008374791
- 3014562978
- 3044026004
- 1219592
- 3020978033
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#
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
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