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#
- 3013674629
- 1926681
- 3034731665
- 1226544
- 3010880816
- 3007327621
- 3006113097
- 3014507028
- 1220477
- 3010952189
- 3004050854
- 1043534
- 1045254
- 3012358417
- 3043562110
- 3015337116
- 3011050570
- 3009403363
- 9611024
- 2028807
- 2135339
- 3014653790
- 2246552
- 3003364789
- 3032857006
- 3002858762
- 1018470
- 1213643
- 3003418325
- 3008719017
- 2031093
- 3016426830
- 3021082429
- 9612051
- 3010872396
- 3009134882
- 3017636737
- 3003775072
- 3002806953
- 3030733800
- 3010487482
- 3017475063
- 9612501
- 1645368
- 3009337401
- 3013187142
- 1424263
- 3005112833
- 3030653921
- 3004146122
- 3006789548
- 1450662
- 3002807315
- 3010951382
- 3015967359
- 1649518
- 2028632
- 3023598220
- 3002789796
- 3022140316
- 3023464160
- 3007225047
- 2183744
- 3011088743
- 3008729892
- 2032098
- 3040335671
- 3004111573
- 3003477135
- 3018094310
- 3008812251
- 3016678045
- 1223089
- 1037007
- 2029275
- 1928237
- 1061124
- 1219071
- 3015174190
- 3013517086
Source Documents#
Other 510(k) Records For Product Code FRO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254168 | Actolind® (06.3637. Actolind® Gel Plus) | ACTO GmbH | 2026-09-22 |
| K254041 | SkinSmart Antimicrobial HydroGel | Magic Science Supply, LLC | 2026-09-11 |
| K261646 | Redermax® Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | 2026-08-14 |
| K253665 | Vashe Plus Antimicrobial Solution | Urgo Medical North America, LLC | 2026-08-11 |
| 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 |
Legacy Summary#
summary
FDA Review#
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