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#
- 3041913476
- 9616572
- 1648579
- 3015140210
- 3017390965
- 3015414875
- 1219103
- 3012421607
- 3013530949
- 3030226294
- 3042251637
- 3004799623
- 3010952189
- 3003887292
- 3015069920
- 3008562678
- 3030017177
- 3038014307
- 3009655869
- 3010034780
- 3027605322
- 3042972928
- 3045058049
- 3003866267
- 3012084379
- 3007663067
- 9610694
- 3038624837
- 3021389253
- 3016807311
- 3027341451
- 3025413691
- 3044026004
- 3008693666
- 3003807757
- 3006784948
- 3045816954
- 3006517436
- 3013530901
- 3011247798
- 3014897003
- 3034605486
- 3010951384
- 3043226252
- 3010018659
- 3016758972
- 3006611176
- 3043026391
- 1054811
- 1058584
- 3031184338
- 2518467
- 3017297225
- 3030067857
- 3011248038
- 3008102042
- 3015337116
- 3045742729
- 3012314549
- 3031582449
- 3022754162
- 3013671177
- 3026263452
- 3038310422
- 3006358042
- 3013521734
- 8030128
- 3042158718
- 3038284048
- 2212018
- 3043105506
- 3040279031
- 1319660
- 3007583554
- 1219592
- 3007607706
- 3008374791
- 3013957847
- 3017210336
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