WAVETRONIC 5000 DIGITAL HF SURGICAL UNIT
FDA 510(k) clearance K134036 · decided 2015-10-08
Clearance details
- K-number
- K134036
- Device name
- WAVETRONIC 5000 DIGITAL HF SURGICAL UNIT
- Applicant
- Loktal Medical Electronics Ind. Com. Ltda- Epp
- Decision
- Substantially Equivalent
- Date received
- 2013-12-31
- Decision date
- 2015-10-08
- Days to decision
- 646 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.