FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIPISYSTEMS AQUAVAGE, MODELS AV2000 AND AV1200
K Number: K092284
·
Decision Sep 1, 2009
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
39
Applicant Total
2
Review Days
34
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Basic Information
- Device Name
- LIPISYSTEMS AQUAVAGE, MODELS AV2000 AND AV1200
- K Number
- K092284
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.5040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medical Device Resource Corp.
- Date Received
- July 29, 2009
- Decision Date
- September 1, 2009
- 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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Other Clearances by Medical Device Resource Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K081593 | POWER ASPIRATOR, MODEL LS2 OR LS2DP | Jul 23, 2008 | Substantially Equivalent |