SYMPHONY DEVICE
FDA 510(k) clearance DEN110011 · decided 2013-12-18
Clearance details
- K-number
- DEN110011
- Device name
- SYMPHONY DEVICE
- Applicant
- Sensory Medical, Inc.
- Decision
- Unknown
- Date received
- 2011-07-13
- Decision date
- 2013-12-18
- Days to decision
- 889 days
- Clearance type
- Post-NSE
- Product code
- OVP
- Device class
- 2
- Regulation number
- 882.5895
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- San Clemente, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.