510(k) K802006
- Device
- TRIANGULAR BANDAGE CAT.#191
- Applicant
- POLLAK (INTL.), LTD.
- 510(k) number
- K802006
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-09-16
- Date received
- 1980-08-20
- 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#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3010388474
- 3003829642
- 3008494300
- 3005761322
- 1000357070
- 3007307589
- 9612388
- 3014144875
- 1038758
- 3012309743
- 1523547
- 1420763
- 3022114800
- 3015214015
- 3014204631
- 3010383831
- 3008676146
- 3011191255
- 3010452421
- 3004777506
- 3021282525
- 1038963
- 3013226
- 3012363901
- 3016964847
- 3025413691
- 1122845
- 3042251612
- 1062671
- 3008008970
- 3005597706
- 3006633581
- 9710641
- 3013632692
- 9616933
- 3007615436
- 2030775
- 9681385
- 1722095
- 3010453133
- 3013374101
- 9611959
- 3034602341
- 1000626221
- 3005273623
- 3003902312
- 1932015
- 3008258694
- 3029900843
- 3011248163
- 3006227741
- 3016050930
- 3010951382
- 3031606416
- 3006517436
- 2110898
- 2921578
- 3008973760
- 1417592
- 3003827835
- 3015337116
- 3004615451
- 3013527364
- 3030539818
- 8030607
- 3013591868
- 3034605486
- 3007392395
- 3007222552
- 3008427684
- 1055236
- 1218386
- 3012464408
- 3004704697
- 3015069920
- 3008311431
- 3005621301
- 3014108257
- 3015526491
- 3015543909
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