MEDXPERT P.E.S. (PECTUS EXACVATUM SYSTEM), MEDXPERT STRATOS
FDA 510(k) clearance K073556 · decided 2008-06-24
Clearance details
- K-number
- K073556
- Device name
- MEDXPERT P.E.S. (PECTUS EXACVATUM SYSTEM), MEDXPERT STRATOS
- Applicant
- Medxpert GmbH
- Decision
- Substantially Equivalent
- Date received
- 2007-12-19
- Decision date
- 2008-06-24
- Days to decision
- 188 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mühlheim An Der Donau, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.