NCONTACT COAGULATION SYSTEM KIT, MODEL CSK
FDA 510(k) clearance K063012 · decided 2006-12-01
Clearance details
- K-number
- K063012
- Device name
- NCONTACT COAGULATION SYSTEM KIT, MODEL CSK
- Applicant
- Ncontact Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-10-02
- Decision date
- 2006-12-01
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- OCL
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Morrisville, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.