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
MUU System, Suction, Lipoplasty

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Other Clearances by Medical Device Resource Corp.

K Number Device Name
K081593 POWER ASPIRATOR, MODEL LS2 OR LS2DP