VERESURE BELL
FDA 510(k) clearance K061387 · decided 2006-07-21
Clearance details
- K-number
- K061387
- Device name
- VERESURE BELL
- Applicant
- Veresure, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-05-18
- Decision date
- 2006-07-21
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- HIF
- Device class
- 2
- Regulation number
- 884.1730
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- San Carlos, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.