FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GLOBAL TREASURES FLUID FILLED TEETHER
K Number: K043033
·
Decision Mar 22, 2005
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
26
Applicant Total
5
Review Days
139
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Basic Information
- Device Name
- GLOBAL TREASURES FLUID FILLED TEETHER
- K Number
- K043033
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5550
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Global Treasure Industries , Ltd.
- Date Received
- November 3, 2004
- Decision Date
- March 22, 2005
- Product Code
- KKO
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KKO | Ring, Teething, Fluid-Filled | FDA class 2 | Dental |
Similar 510(k) Clearances
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Other Clearances by Global Treasure Industries , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K062010 | RAPID DIGITAL THERMOMETER, MODEL RDT -18 SERIES | Oct 27, 2006 | Substantially Equivalent |
| K030673 | FLEXIBLE TIP THERMOMETER, MODEL 011206 | Apr 4, 2003 | Substantially Equivalent |
| K030658 | STANDARD THERMOMETER | Mar 25, 2003 | Substantially Equivalent |
| K021052 | MODEL GT010706 ELECTRONIC THERMOMETER | Apr 9, 2002 | Substantially Equivalent |