ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIP
FDA 510(k) clearance K053282 · decided 2005-12-13
Clearance details
- K-number
- K053282
- Device name
- ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIP
- Applicant
- Pajunk GmbH
- Decision
- Substantially Equivalent
- Date received
- 2005-11-25
- Decision date
- 2005-12-13
- Days to decision
- 18 days
- Clearance type
- Special
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Geisingen, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.