FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
POWERPRO BATTERY SYSTEM
K Number: K012320
·
Decision Oct 19, 2001
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
1
Applicant Total
93
Review Days
88
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Basic Information
- Device Name
- POWERPRO BATTERY SYSTEM
- K Number
- K012320
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Linvatec Corp.
- Date Received
- July 23, 2001
- Decision Date
- October 19, 2001
- Product Code
- HAB
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| HAB | Saw, Powered, And Accessories | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HAB), ordered by most recent decision date.
View allOther Clearances by Linvatec Corp.
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