FDA 510(k)
FDA class 1
Substantially Equivalent
🇦🇹 Austria
PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500
K Number: K070287
·
Decision Feb 12, 2007
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
9
Applicant Total
1
Review Days
14
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Basic Information
- Device Name
- PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500
- K Number
- K070287
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Photonic Optische Gerate GmbH & Cokg
- Date Received
- January 29, 2007
- Decision Date
- February 12, 2007
- Product Code
- EBA
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EBA | Light, Surgical Headlight | FDA class 1 | Dental |
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