X6000D SILENT SUN LIGHT SOURCE
FDA 510(k) clearance K955510 · decided 1996-01-31
Clearance details
- K-number
- K955510
- Device name
- X6000D SILENT SUN LIGHT SOURCE
- Applicant
- Products For Medicine
- Decision
- Substantially Equivalent
- Date received
- 1995-12-04
- Decision date
- 1996-01-31
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- FST
- Device class
- 2
- Regulation number
- 878.4580
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.