510(k) K123904
- Device
- PROTHELIAL
- Applicant
- MUELLER MEDICAL INTERNATIONAL LLC
- 510(k) number
- K123904
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-08-07
- Date received
- 2012-12-19
- 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
- RICKY W MCCULLOUGH MD
- Address
- 48a Moosup Valley Rd. Foster RI US 02825 02825
FDA Registration Numbers#
- 3012456427
- 1648579
- 3016851379
- 3012026312
- 3010400367
- 3012111117
- 3007582648
- 3027815
- 3030625176
- 3017297225
- 8030673
- 2022435
- 3009848807
- 3016116741
- 2953359
- 3007321028
- 1643817
- 3005460813
- 1018120
- 8043792
- 3009756327
- 3009701308
- 1034876
- 3014146451
- 2183744
- 3017396949
- 3019843904
- 3025431504
- 3012448339
- 1047843
- 3000268902
- 3004637474
- 1645368
- 3010160527
- 3009348823
- 3009109670
- 3010770024
- 3004170064
- 1225598
- 3007544634
- 1719513
- 2124143
- 3018161300
- 3005533873
- 3018153007
- 3007120504
- 3012421607
- 3037918935
- 1423537
- 3008808082
- 9680357
- 3004799623
- 1929833
- 2135152
- 3006633581
- 3030926959
- 3003477135
- 3008562678
- 1649518
- 3011191255
- 3007841320
- 3004496953
- 3009461428
- 8030128
- 3009344179
- 2530957
- 3016603542
- 2031987
- 3027529701
- 3007648359
- 2529394
- 3014421917
- 3004727227
- 2280705
- 3003617485
- 3009176340
- 3003524577
- 3026399481
- 3019944216
- 3006621348
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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