CANDELA URETHRAL/BLADDER SOUND
FDA 510(k) clearance K950633 · decided 1995-03-06
Clearance details
- K-number
- K950633
- Device name
- CANDELA URETHRAL/BLADDER SOUND
- Applicant
- Candela Laser Corp.
- Decision
- Substantially Equivalent
- Date received
- 1995-02-13
- Decision date
- 1995-03-06
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- FBX
- Device class
- 1
- Regulation number
- 876.5520
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Wayland, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.