NEEDLE ELCTRODE
FDA 510(k) clearance K944265 · decided 1995-05-05
Clearance details
- K-number
- K944265
- Device name
- NEEDLE ELCTRODE
- Applicant
- Unimed Surgical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-09-01
- Decision date
- 1995-05-05
- Days to decision
- 246 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
- Largo, FL, US
- Third-party review
- No
- Expedited review
- No
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