510(k) K871458
- Device
- SURVIVAL KIT, INDIVIDUAL, TROP, TACTICAL AIR CREW
- Applicant
- FRAASS SURVIVAL SYSTEMS, INC.
- 510(k) number
- K871458
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-07-09
- Date received
- 1987-04-13
- 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
- PATRICK A MALIA
- Address
- 3830 Boston Rd. Bronx NY US 10475 10475
FDA Registration Numbers#
- 1123137
- 3007123908
- 2245304
- 1060680
- 3009703496
- 3004892425
- 9611024
- 1000614268
- 3010041511
- 1226074
- 3007420745
- 3010131137
- 3018544165
- 3005083075
- 3015173212
- 3011525245
- 3004519921
- 3033589330
- 1313525
- 3016215282
- 2245270
- 3014457631
- 3006673317
- 3012568936
- 3005669815
- 3013756169
- 9615765
- 1035236
- 1820334
- 1219930
- 3015058854
- 3039406055
- 3006191977
- 3010659131
- 3015487912
- 1034876
- 1526611
- 3020468145
- 3004992978
- 9617977
- 2531684
- 3013530901
- 3009746061
- 1417592
- 9681465
- 3023191945
- 3011499367
- 3014644369
- 3015143057
- 3030067857
- 3006542380
- 3023265483
- 3016171914
- 3010155661
- 1721504
- 3014637079
- 3012478585
- 3010470577
- 3006950086
- 3004125670
- 3009495876
- 3013840437
- 3019798849
- 8010273
- 1211566
- 3013307971
- 9680002
- 3011680076
- 3012130008
- 3008902714
- 3010462278
- 3003139373
- 8044099
- 3018094310
- 1643817
- 3008812560
- 3007607706
- 1526534
- 3022862651
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