FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Automatic Tissue Processing Unit
K Number: K172717
·
Decision May 25, 2018
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
39
Applicant Total
1
Review Days
259
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Basic Information
- Device Name
- Automatic Tissue Processing Unit
- K Number
- K172717
- 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
- Bsl Co.
- Date Received
- September 8, 2017
- Decision Date
- May 25, 2018
- Product Code
- MUU
- 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 |
|---|---|---|---|
| MUU | System, Suction, Lipoplasty | FDA class 2 | General, Plastic Surgery |
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