FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
VIP 60 (2H), MODEL 115-000-1, VIP 60 (4H), MODEL 115-000-2
K Number: K991239
·
Decision Oct 18, 1999
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
194
Applicant Total
3
Review Days
189
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Basic Information
- Device Name
- VIP 60 (2H), MODEL 115-000-1, VIP 60 (4H), MODEL 115-000-2
- K Number
- K991239
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4850
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Micron Corp.
- Date Received
- April 12, 1999
- Decision Date
- October 18, 1999
- Product Code
- ELC
- 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 |
|---|---|---|---|
| ELC | Scaler, Ultrasonic | FDA class 2 | Dental |
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