Gore-Tex Regenerative Material
by W. L. Gore & Associates, Inc.
510(k) K922627
Gore-Tex Regenerative Material is a Class II device made by W. L. Gore & Associates, Inc., cleared under FDA 510(k) K922627 on 10 Jun 1994, active as of 12 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 | NumberK922627 | Date10 Jun 1994 | StatusActive |
Official records
- FDA 510(k) database K922627
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NPK
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3930
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
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