LYOPLANT ONLAY
FDA 510(k) clearance K122791 · decided 2013-06-04
Clearance details
- K-number
- K122791
- Device name
- LYOPLANT ONLAY
- Applicant
- Aesculap, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-09-12
- Decision date
- 2013-06-04
- Days to decision
- 265 days
- Clearance type
- Traditional
- Product code
- GXQ
- Device class
- 2
- Regulation number
- 882.5910
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Center Valley, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.