Modification to Skvekpatch
by Marine Polymer Technologies, Inc.
510(k) K984177
Modification to Skvekpatch is a Class I device made by Marine Polymer Technologies, Inc., cleared under FDA 510(k) K984177 on 18 Dec 1998, 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)SN | NumberK984177 | Date18 Dec 1998 | StatusActive |
Official records
- FDA 510(k) database K984177
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- Withdrawn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
- SN
Devices cleared under K984177
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 | |||
|---|---|---|---|---|
| Syvek Patch 400-02 | 400-02 | 00389142000087 | — | On the market |
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