FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
BODY-JET
K Number: K082025
·
Decision Aug 13, 2008
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
57
Applicant Total
2
Review Days
27
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Basic Information
- Device Name
- BODY-JET
- K Number
- K082025
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Human Med AG
- Date Received
- July 17, 2008
- Decision Date
- August 13, 2008
- Product Code
- QPB
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| QPB | System, Suction, Lipoplasty For Removal | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Human Med AG
| K Number | Device Name | ||
|---|---|---|---|
| K101713 | LIPCOLLECTOR II | Jun 29, 2010 | Substantially Equivalent |