Basic, Dominant Flex
FDA 510(k) clearance K170329 · decided 2017-03-24
Clearance details
- K-number
- K170329
- Device name
- Basic, Dominant Flex
- Applicant
- Modela AG
- Decision
- Substantially Equivalent
- Date received
- 2017-02-02
- Decision date
- 2017-03-24
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- QPB
- Device class
- 2
- Regulation number
- 878.5040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Baar, CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.