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
Related Records
Applicant Contact
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers
- 3022133572
- 1423537
- 3017210336
- 3009662219
- 3010131715
- 3011987967
- 3005343641
- 3010256218
- 3012777736
- 3017297225
- 3008979241
- 3042205143
- 3013226
- 1219103
- 3021013122
- 3031092085
- 3016450032
- 3011247798
- 3012084379
- 3008044603
- 3007289408
- 3012706495
- 3016615875
- 3038310422
- 2954718
- 3031841433
- 3021389253
- 3041913476
- 3006897996
- 3007607706
- 3005761322
- 3033536319
- 3007028040
- 3042972928
- 3003887292
- 1646434
- 3007663067
- 3017417635
- 9616572
- 1052728
- 3031582434
- 3042283853
- 1649690
- 2218158
- 3030067857
- 3043026391
- 8030128
- 2530957
- 3010392991
- 3022754162
- 3011529314
- 3018101380
- 3014666579
- 3016758972
- 3007307589
- 3007766648
- 1226486
- 3012034017
- 3013957847
- 3009540516
- 3039386251
- 3004957256
- 3006253843
- 3009482034
- 3043105506
- 3010814025
- 3017633586
- 3003807757
- 1648579
- 3008374791
- 3012481754
- 3042158718
- 3030226294
- 3007594734
- 3036978602
- 3014848316
- 3032911850
- 3007327621
- 3017896419
Source Documents
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FRO
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|---|---|---|---|
| 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