ET PROSTHETIC SYSTEM
FDA 510(k) clearance K130662 · decided 2014-01-10
Clearance details
- K-number
- K130662
- Device name
- ET PROSTHETIC SYSTEM
- Applicant
- Osstem Implant Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2013-03-12
- Decision date
- 2014-01-10
- Days to decision
- 304 days
- Clearance type
- Traditional
- Product code
- NHA
- Device class
- 2
- Regulation number
- 872.3630
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Fariless Hills, PA, US
- Third-party review
- No
- Expedited review
- No
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