SIDE EFFECT WITH HAND CONTROLS, HOOK ELECTRODE WITH HAND CONTROLS, 2.3 WEDGE ELECTRODE WITH HAND CONTROLS, S90 WITH HAND
FDA 510(k) clearance K120095 · decided 2012-04-06
Clearance details
- K-number
- K120095
- Device name
- SIDE EFFECT WITH HAND CONTROLS, HOOK ELECTRODE WITH HAND CONTROLS, 2.3 WEDGE ELECTRODE WITH HAND CONTROLS, S90 WITH HAND
- Applicant
- Depuy Mitek, A Johnson & Johnson Company
- Decision
- Substantially Equivalent
- Date received
- 2012-01-12
- Decision date
- 2012-04-06
- Days to decision
- 85 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
- Raynham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.