THE WAND
FDA 510(k) clearance K992404 · decided 2000-06-06
Clearance details
- K-number
- K992404
- Device name
- THE WAND
- Applicant
- Spintech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-07-19
- Decision date
- 2000-06-06
- Days to decision
- 323 days
- Clearance type
- Traditional
- Product code
- FMF
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.