510(k) K081635
- Device
- INTEGRA MESHED BILAYER WOUND MATRIX
- Applicant
- INTEGRA LIFESCIENCES CORP.
- 510(k) number
- K081635
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-12-04
- Date received
- 2008-06-11
- 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
- U
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DIANA M BORDON
- Address
- 311 Enterprise Dr. Planisboro NJ US 08536 08536
FDA Registration Numbers#
- 3012535730
- 3003300673
- 3007735241
- 3009504230
- 1645368
- 1720929
- 3015282703
- 3004799623
- 3014146451
- 3017399129
- 1220477
- 2245304
- 3031600472
- 3009317711
- 1000393132
- 1066741
- 1047843
- 3011276344
- 8043396
- 3016904853
- 1720734
- 1043214
- 3007738736
- 3027517726
- 3004189237
- 9680579
- 2431866
- 3013012623
- 3032911850
- 3042617688
- 3011649314
- 3009882464
- 3012823434
- 3005920706
- 3015525200
- 1221816
- 3042750477
- 2030598
- 3012448339
- 3009109670
- 3030067857
- 3034456223
- 1646434
- 3009973323
- 1929833
- 3011191255
- 1650372
- 2135152
- 1531062
- 3017297225
- 1319660
- 3036710971
- 3015309358
- 3008770963
- 3017660750
- 3012973796
- 1121308
- 1060680
- 3010824458
- 3008374791
- 1649518
- 3012102437
- 3013517171
- 2530154
- 3010668881
- 3009656988
- 3025316685
- 2245539
- 9614442
- 3010894343
- 3007594734
- 3015946784
- 3010155661
- 3003768919
- 2032542
- 9680091
- 3015238043
- 8043792
- 3014820861
Source Documents#
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#
summary
FDA Review#
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