FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MEISINGER BENEX, MODEL BE001
K Number: K062130
·
Decision Apr 16, 2007
Classifications
1
FEI Numbers
203
Registration Numbers
203
Same Product Code
9
Applicant Total
14
Review Days
264
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Basic Information
- Device Name
- MEISINGER BENEX, MODEL BE001
- K Number
- K062130
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Hager& Meisinger GmbH
- Date Received
- July 26, 2006
- Decision Date
- April 16, 2007
- Product Code
- EMG
- 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 |
|---|---|---|---|
| EMG | Forceps, Tooth Extractor, Surgical | FDA class 1 | Dental |
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