510(k) K820105
- Device
- COMBINE PAD OR ABD
- Applicant
- STAN-PAK ENT.
- 510(k) number
- K820105
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-02-05
- Date received
- 1982-01-15
- 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#
- 1422634
- 3007344957
- 3010621964
- 3031167704
- 3022954003
- 3008386507
- 3015895045
- 3034669683
- 3004513970
- 3038162648
- 3002637602
- 1053541
- 1423662
- 3010864832
- 3008264111
- 3030896267
- 3019315696
- 3008851420
- 3005951296
- 2083545
- 3008485841
- 3017297225
- 3009114792
- 3017107376
- 3012050423
- 3016452400
- 3004125670
- 3012818008
- 3010374972
- 3007480628
- 3003403221
- 3011849720
- 3039394934
- 3007299770
- 3004753358
- 3007187674
- 3007966889
- 3005558160
- 3009605026
- 3042367543
- 3035786158
- 1054241
- 3042283853
- 1052728
- 3015437221
- 3038274448
- 3010583458
- 3039388855
- 3011767135
- 3003915875
- 3008255748
- 3025384290
- 3005112833
- 3009167225
- 3033011342
- 9616518
- 3003887292
- 3042032212
- 9616872
- 3008494300
- 3031184338
- 3011238790
- 3012660022
- 3016195240
- 3045857302
- 3011434305
- 3009756153
- 3010967704
- 3010339057
- 3012421607
- 3007305426
- 3014146451
- 3015378469
- 1250045
- 3013632692
- 9612354
- 3017367014
- 3017095924
- 3018228713
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