510(k) K850076
- Device
- WOUND DRESSING MODEL ZB-6
- Applicant
- THERMEDICS, INC.
- 510(k) number
- K850076
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-04-15
- Date received
- 1985-01-09
- 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#
- Contact
- MURFITT
- Address
- 470 Wildwood St. P.O. Box 2697 Woburn MA US 01888 01888
FDA Registration Numbers#
- 3008392077
- 3003530017
- 9681544
- 3015375647
- 3004911384
- 3032812695
- 3019804885
- 2320762
- 3023191945
- 3015781296
- 3004547763
- 3005858760
- 3011088743
- 3006425876
- 3022085015
- 1419520
- 3034531759
- 3005841027
- 3015277818
- 2183416
- 3011862887
- 3007607706
- 3015416207
- 1925025
- 3005034064
- 9616088
- 3030067857
- 3009167225
- 3013525704
- 3033520596
- 9616874
- 3030333982
- 3010288357
- 8010485
- 3042261316
- 3010273867
- 3021228307
- 3030017177
- 3030626857
- 3007841320
- 3031233007
- 1649518
- 3007125968
- 3006371704
- 3008386507
- 2031094
- 3023917
- 3017235663
- 3010160370
- 3010621964
- 9610694
- 3014368824
- 3004176951
- 1219795
- 3008392711
- 3031288561
- 3033536319
- 3007282994
- 3007007790
- 3008559295
- 3014747754
- 3015821396
- 3004022422
- 3014195785
- 3006210673
- 3021013122
- 3013530949
- 3010305275
- 2320961
- 1930027
- 3013557562
- 2648727
- 3011307048
- 2939142
- 3008102042
- 3018507299
- 1037885
- 1123137
- 3020188747
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#
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
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