IGI-SYSTEM
FDA 510(k) clearance K052840 · decided 2005-12-16
Clearance details
- K-number
- K052840
- Device name
- IGI-SYSTEM
- Applicant
- Denx Advanced Dental Systems
- Decision
- Substantially Equivalent
- Date received
- 2005-10-07
- Decision date
- 2005-12-16
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- HAW
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Jerusalem, Al, IL
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.