Model 550-Dc Crossfire(Tm)
510(k) K945564
Model 550-Dc Crossfire(Tm) is a Class II device made by Eclipse, Inc., cleared under FDA 510(k) K945564 on 1 Jun 1995, 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 | NumberK945564 | Date1 Jun 1995 | StatusActive |
Official records
- FDA 510(k) database K945564
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEX
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
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