ONCOBIONIC SYSTEM
FDA 510(k) clearance K060054 · decided 2006-11-21
Clearance details
- K-number
- K060054
- Device name
- ONCOBIONIC SYSTEM
- Applicant
- Oncobionics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-01-06
- Decision date
- 2006-11-21
- Days to decision
- 319 days
- Clearance type
- Traditional
- Product code
- OAB
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.