510(k) K842064
- Device
- ACU-DERM TRANSPARENT IV DRESSING
- Applicant
- ACME UNITED CORP.
- 510(k) number
- K842064
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-08-15
- Date received
- 1984-05-21
- 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#
- 3012680643
- 1423507
- 9611590
- 3009504230
- 9614279
- 3014146451
- 3011237770
- 3003152976
- 1125782
- 1000317571
- 1928237
- 1220477
- 3015335956
- 3009548473
- 3005112833
- 3009668937
- 1721504
- 3012798826
- 1047843
- 1724474
- 2182318
- 9616791
- 2521402
- 3031841433
- 2030624
- 3015859709
- 3033891906
- 3003835287
- 3004102031
- 3007207474
- 3031233007
- 1423537
- 3023316
- 3014421917
- 1043214
- 1000563940
- 1420054
- 3027517726
- 3044707998
- 3012084379
- 3015821396
- 3017059795
- 1319454
- 3009756327
- 3003915875
- 3032911850
- 3021090069
- 3016674858
- 2243072
- 3031564213
- 3014579161
- 3031757047
- 3045857302
- 8030607
- 3042840696
- 3013122778
- 1647149
- 1320894
- 3009491738
- 3011137372
- 3042903214
- 3021562887
- 1722684
- 9617744
- 9680271
- 1054811
- 3001576493
- 2183744
- 3016803464
- 3045816939
- 3007289408
- 3042272797
- 3003974574
- 1220648
- 3013764800
- 3035451914
- 3012480535
- 9680794
- 3012536737
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