FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

LIPO CANNULA

K Number: K081039 · Decision Jul 10, 2008
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
57
Applicant Total
5
Review Days
90

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Basic Information

Device Name
LIPO CANNULA
K Number
K081039
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
878.5040
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Millennium Medical Technologies, Inc.
Date Received
April 11, 2008
Decision Date
July 10, 2008
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
QPB System, Suction, Lipoplasty For Removal

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Other Clearances by Millennium Medical Technologies, Inc.

K Number Device Name
K170449 Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml, Autoclavable Suction Jar without Luer Lock extension - 1,500 and 2,500 ml, Sterile 1,500 and 2,500 Lids with Conical patient connection 6-10 and overflow protection
K031050 PCW PERCUTANEOUS COMPRESSION WIRE
K020791 HBS HEADLESS BONE SCREW
K012294 WRISTORE FIXATOR