GLOBAL TREASURES FLUID FILLED TEETHER
FDA 510(k) clearance K043033 · decided 2005-03-22
Clearance details
- K-number
- K043033
- Device name
- GLOBAL TREASURES FLUID FILLED TEETHER
- Applicant
- Global Treasure Industries , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2004-11-03
- Decision date
- 2005-03-22
- Days to decision
- 139 days
- Clearance type
- Traditional
- Product code
- KKO
- Device class
- 2
- Regulation number
- 872.5550
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Beverly, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.