FDA 510(k)
FDA class 1
Substantially Equivalent
🇩🇪 Germany
PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM
K Number: K080674
·
Decision May 9, 2008
Classifications
1
FEI Numbers
67
Registration Numbers
67
Same Product Code
6
Applicant Total
44
Review Days
60
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Basic Information
- Device Name
- PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM
- K Number
- K080674
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PAJUNK GmbH Medizintechnologie
- Date Received
- March 10, 2008
- Decision Date
- May 9, 2008
- Product Code
- MJG
- 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 |
|---|---|---|---|
| MJG | Device, Percutaneous, Biopsy | FDA class 1 | General, Plastic Surgery |
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