510(k) K892364
- Device
- KALTOSTAT(TM) WOUND DRESSING
- Applicant
- CALGON VESTAL DIV.
- 510(k) number
- K892364
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-06-23
- Date received
- 1989-04-06
- 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
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD C JENTE
- Address
- P.O. Box 147 St. Louis MO US 63166 63166
FDA Registration Numbers#
- 1123137
- 3015821396
- 3033530347
- 2245304
- 3018507299
- 1060680
- 3006802076
- 3027529701
- 3027590916
- 3043618351
- 3013133723
- 3007502289
- 1221816
- 3030691709
- 3013521734
- 1043549
- 3017552041
- 3017509841
- 3007187674
- 3003636207
- 2530957
- 3005669815
- 3015547002
- 3029971427
- 9610694
- 3011191255
- 3021784063
- 3017396949
- 3036978602
- 3012979524
- 3007662962
- 3003755939
- 3015058854
- 9710608
- 2218158
- 1720929
- 3006784948
- 3009486864
- 3006946276
- 1034876
- 3013557562
- 3011689956
- 3025431504
- 3009109670
- 1417592
- 1018120
- 3009848807
- 3005674466
- 3006218807
- 3010610560
- 1417519
- 3016450032
- 3030067857
- 3006052875
- 3015309358
- 3010155661
- 3017517906
- 3003622638
- 3009348823
- 3004125670
- 3004496953
- 3007544634
- 3030229896
- 3004170064
- 3010407203
- 3023113877
- 3038356900
- 3015142802
- 3010131715
- 1225532
- 3008396914
- 1819174
- 1643817
- 3007120504
- 3015374187
- 3015077448
- 9614157
- 3004681519
- 3030692786
Source Documents#
510(k) summary PDF not indicated by FDA
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#
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