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#
- 3010659131
- 2320762
- 3023191945
- 3013421458
- 3015859709
- 3012187635
- 3008627763
- 3023339277
- 1223004
- 3016215282
- 3011862887
- 3004892425
- 3007139365
- 3007607706
- 3009189869
- 3015416207
- 3005034064
- 9616088
- 3030067857
- 3006271008
- 3016826509
- 9612030
- 1017294
- 1649518
- 1123010
- 3033589330
- 3045816907
- 3010583458
- 3003597504
- 8010273
- 2032098
- 3003759558
- 3005108347
- 3007007790
- 3008559295
- 3005897698
- 3007697249
- 1030451
- 2648623
- 3013840437
- 8040278
- 3008467060
- 1222773
- 2431166
- 3002808466
- 9617229
- 3006217744
- 3010667733
- 1123137
- 3007597038
- 9617977
- 3018116884
- 3003604053
- 3019798849
- 9680794
- 3018503755
- 2032112
- 3005675811
- 3016170492
- 1836161
- 3004638532
- 9613083
- 2183744
- 3008824097
- 3011137372
- 3023464160
- 2433012
- 3002807115
- 3022132808
- 2022435
- 3016248648
- 3012536737
- 3010178296
- 3029082594
- 1219602
- 3011680076
- 3025168
- 1047843
- 3009888344
- 1420054
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#
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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