FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HK LIPOSUCTION ASPIRATOR, MODEL AP-III & AP230-III
K Number: K032802
·
Decision Nov 19, 2003
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
57
Applicant Total
3
Review Days
71
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Basic Information
- Device Name
- HK LIPOSUCTION ASPIRATOR, MODEL AP-III & AP230-III
- K Number
- K032802
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 878.5040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hk Surgical, Inc.
- Date Received
- September 9, 2003
- Decision Date
- November 19, 2003
- Product Code
- QPB
- 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 |
|---|---|---|---|
| QPB | System, Suction, Lipoplasty For Removal | FDA class 2 | General, Plastic Surgery |
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