510(k) K150916
- Device
- HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO
- Applicant
- HemCon Medical Technologies, Inc.
- 510(k) number
- K150916
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-11-10
- Date received
- 2015-04-06
- 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
- U
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jody Oyama
- Address
- 720 SW Washington St., Suite 200 Portland OR US 97225 97225
FDA Registration Numbers#
- 2244725
- 2032542
- 3006950086
- 9611590
- 1061124
- 8043838
- 3010155661
- 3012888343
- 3033589330
- 3011088743
- 3012777736
- 1424263
- 3025413691
- 9681465
- 3007735241
- 1213643
- 3031563325
- 3004740112
- 3011137372
- 3002808227
- 3014136088
- 3016844359
- 3009348684
- 3005378067
- 3010878315
- 3007788086
- 3038718579
- 1038758
- 1250045
- 3008298053
- 1054811
- 3004050854
- 1220477
- 1417592
- 3005761322
- 2245304
- 3006113097
- 3004512585
- 9680091
- 3011657181
- 3007215524
- 1423662
- 3015422337
- 1721504
- 3015219237
- 9614493
- 3005674475
- 3022104448
- 8043396
- 1018233
- 2135152
- 9680271
- 3010864832
- 3004138549
- 1450662
- 3015525200
- 1066421
- 3027815
- 3006619672
- 3002807310
- 3007225047
- 3010256218
- 3015437221
- 3006082230
- 1625425
- 9616067
- 3001186500
- 3005853033
- 1219313
- 2183319
- 3015205402
- 3005460813
- 3012536737
- 3007583554
- 3009317711
- 3009756327
- 3015225571
- 3021841055
- 3003898360
Source Documents#
Other 510(k) Records For Product Code FRO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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#
summary
FDA Review#
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