510(k) K896421
- Device
- TRANSPARENT FILM I.V. SITE/WOUND DRESSING
- Applicant
- CATALINA BIOMEDICAL CORP.
- 510(k) number
- K896421
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-01-31
- Date received
- 1989-11-08
- 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
- J ROGOZINSKI
- Address
- 1850 Evergreen St. Duarte CA US 91010 91010
FDA Registration Numbers#
- 2523676
- 1931876
- 2027062
- 3024844185
- 1314417
- 1422634
- 3043496870
- 3033589330
- 1223925
- 9617744
- 1836161
- 3042840696
- 3012084379
- 3012543139
- 3035451914
- 1423662
- 9610825
- 3004022422
- 3004102031
- 3006542380
- 3043354155
- 3023316
- 3021562887
- 3007124979
- 1954553
- 3013517171
- 3009756327
- 3030733800
- 1420054
- 3004365956
- 3003636207
- 3009504230
- 3027977504
- 3014421917
- 1000374440
- 3013122778
- 3030433705
- 1721676
- 2243072
- 3013075752
- 1313046
- 3016863553
- 3021090069
- 3012480535
- 3016674858
- 3003152976
- 3008374791
- 3044707998
- 3006950086
- 3007289408
- 1647149
- 3012536737
- 3009701308
- 3011642792
- 3013298431
- 3016803464
- 2182318
- 3031233007
- 3025337868
- 1036836
- 2032677
- 1047843
- 2022388
- 3017636737
- 8020785
- 3010452421
- 9616088
- 1018470
- 1724474
- 3013188547
- 3005023997
- 3003915875
- 1018233
- 1721504
- 3031757047
- 3010824458
- 8030941
- 3013415761
- 3005112833
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