Norsen Debrider
510(k) K800647
Norsen Debrider is a Class I device made by Medline Industries, Inc., cleared under FDA 510(k) K800647 on 16 Apr 1980, 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 | NumberK800647 | Date16 Apr 1980 | StatusActive |
Official records
- FDA 510(k) database K800647
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEN
- Device class
- Class I
- Regulation
- 21 CFR Part 878.4800
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
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