510(k) K780549
- Device
- NON-STICK PADS
- Applicant
- NATIONAL PATENT DEVELOPMENT CORP.
- 510(k) number
- K780549
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-04-19
- Date received
- 1978-04-05
- 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#
- 3004513970
- 3023341288
- 3010515547
- 3010598169
- 3012034017
- 3034669683
- 3013034812
- 2245304
- 1037007
- 3032507796
- 3031600086
- 3032172199
- 1047843
- 3038718579
- 2182318
- 3011862887
- 1038758
- 3021286079
- 3003835287
- 1421873
- 3010380285
- 3013735158
- 3019804885
- 3014421917
- 3021282544
- 3039394934
- 3005735974
- 3013421458
- 3017059795
- 3027234828
- 3045855232
- 3044819802
- 2031508
- 3002637602
- 3009403363
- 3008294339
- 3016833936
- 3008264111
- 3035786158
- 3007028032
- 3007417776
- 3015379055
- 3026536498
- 3020460367
- 3011137372
- 3009167225
- 3030067857
- 1055236
- 3016452400
- 3012777736
- 3010034780
- 3007307589
- 3010864832
- 3004361903
- 3006847937
- 2135152
- 3035523371
- 3018228713
- 1319660
- 1025972
- 3010951382
- 3015214015
- 9614157
- 3003965134
- 3004569180
- 9611459
- 3015422337
- 3008663306
- 9616872
- 3013497020
- 3003528228
- 3008076203
- 3044905091
- 3013523368
- 3015139713
- 2028046
- 3012922212
- 2086484
- 3014683120
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