Mrdh Bandage
by Marine Polymer Technologies, Inc.
510(k) K082703
Mrdh Bandage is a Class I device made by Marine Polymer Technologies, Inc., cleared under FDA 510(k) K082703 on 14 Oct 2008, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK082703 | Date14 Oct 2008 | StatusActive |
Official records
- FDA 510(k) database K082703
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KMF
- Device class
- Class I
- Regulation
- 21 CFR Part 880.5090
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K082703
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| mrdh bandage 10 cm x 10 cm 400-14 | 400-14 | 00389142000117 | — | On the market |
| mrdh Bandage 5 cm x 5 cm 400-25 | 400-25 | 00389142000124 | — | On the market |
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