510(k) K080247
- Device
- QUIKCLOT NOSEBLEED
- Applicant
- Z-MEDICA CORPORATION
- 510(k) number
- K080247
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-02-27
- Date received
- 2008-01-31
- 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
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RONALD E PETERSON
- Address
- 4 Fairfield Blvd. Wallingford CT US 06492 06492
FDA Registration Numbers#
- 3022140316
- 3015967359
- 1526711
- 1625425
- 3003775072
- 1061124
- 3030653921
- 3010951382
- 9611024
- 3013517086
- 3006306415
- 3003477135
- 3008729892
- 3016050930
- 3010880816
- 3004146122
- 9612501
- 3004111573
- 1226544
- 3002806953
- 3015174190
- 3006524618
- 2183319
- 2135339
- 3010610457
- 2183744
- 3040335671
- 3032857006
- 3010951384
- 1450662
- 2031093
- 1928237
- 3002858762
- 3002807315
- 3014345718
- 3007788086
- 3010952189
- 3011050570
- 1645368
- 3004050854
- 1424263
- 1018470
- 3016678045
- 3021082429
- 1219795
- 3010273872
- 3003915875
- 2110420
- 3003418325
- 8010177
- 3005112833
- 3015337116
- 3030733800
- 3007327621
- 1058584
- 9612051
- 3011400126
- 1213643
- 3023464160
- 3007225047
- 3017636737
- 2028632
- 3010487482
- 1649518
- 3006345872
- 3003364789
- 1037007
- 3034731665
- 3002789796
- 1223089
- 3009403363
- 2029275
- 1319660
- 3008812251
- 2246552
- 2028807
- 3010872396
- 3012448339
- 1643264
- 3012358417
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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