FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
I-SURGE
K Number: K071965
·
Decision Sep 10, 2007
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
260
Applicant Total
24
Review Days
56
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Basic Information
- Device Name
- I-SURGE
- K Number
- K071965
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Satelec
- Date Received
- July 16, 2007
- Decision Date
- September 10, 2007
- Product Code
- EFB
- 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 |
|---|---|---|---|
| EFB | Handpiece, Air-Powered, Dental | FDA class 1 | Dental |
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