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#
- 1034876
- 1422634
- 3010459874
- 3015895045
- 3006271008
- 3033796310
- 3004513970
- 1836161
- 2024311
- 3004941127
- 2936485
- 1121091
- 3013666218
- 9612327
- 2531684
- 3009996260
- 3003759558
- 1820334
- 3008559295
- 3008627763
- 3032747418
- 3004125670
- 3007697249
- 3020468145
- 1032347
- 1054241
- 3009888344
- 3010583458
- 3011707784
- 3015143057
- 3009703496
- 1018470
- 3003882387
- 9616872
- 3031184338
- 1211566
- 3010041511
- 3013443304
- 2183744
- 3016195240
- 3045857302
- 3003807268
- 2649614
- 3009340886
- 3010470577
- 3005083075
- 3014146451
- 9680002
- 3006638824
- 1718873
- 9615765
- 3016248648
- 3016170492
- 3007139365
- 3008338766
- 3008676146
- 3006554788
- 3030516433
- 2530138
- 3004111573
- 3006617885
- 9612030
- 9681465
- 3012187635
- 3043620689
- 3012568936
- 3015173212
- 3016068274
- 1054811
- 9617977
- 1055236
- 3005897698
- 3010462278
- 3017607477
- 3005325790
- 3007007790
- 1226074
- 2029275
- 3015309643
- 3007663067
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