510(k) K871495
- Device
- BANDAGES CATALOG NUMBER: 101 TO 220
- Applicant
- I M, INC.
- 510(k) number
- K871495
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-05-08
- Date received
- 1987-04-16
- 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
- AMIR PORAT
- Address
- P.O. Box 658 Fairfield NJ US 07004 07004
FDA Registration Numbers#
- 1034876
- 1422634
- 3009109670
- 3010621964
- 3043041704
- 3042277868
- 3008386507
- 3011210302
- 3039386251
- 3034669683
- 1836161
- 1219795
- 3038356900
- 3003775072
- 3009171251
- 1423662
- 3030421258
- 3008264111
- 3023316
- 3008572121
- 3003799320
- 3008485841
- 3017297225
- 1000118068
- 3008559295
- 3017107376
- 9710020
- 3011881316
- 3009504230
- 3004448390
- 3010419931
- 3016904853
- 3003403221
- 3007187674
- 3014437893
- 3007966889
- 3004857344
- 3031233007
- 1054241
- 3004102812
- 3042283853
- 1052728
- 3039435289
- 3038274448
- 3008392077
- 3006371704
- 3039388855
- 3011707784
- 1018470
- 1018233
- 3006606901
- 3009167225
- 8032044
- 3011987967
- 3005004019
- 1644312
- 3029971427
- 3010305275
- 3002807090
- 3043503913
- 3003887292
- 9616872
- 3017036472
- 3031184338
- 3011238790
- 3029894475
- 3036035308
- 3045857302
- 1480288
- 3012465068
- 1629057
- 3031218457
- 3010339057
- 3012421607
- 3014146451
- 3015378469
- 3008132411
- 3013510154
- 3032911850
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