FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

LIPCOLLECTOR II

K Number: K101713 · Decision Jun 29, 2010
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
39
Applicant Total
2
Review Days
11

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Basic Information

Device Name
LIPCOLLECTOR II
K Number
K101713
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
Human Med AG
Date Received
June 18, 2010
Decision Date
June 29, 2010
Product Code
MUU
Advisory Committee
General, Plastic Surgery
Review Advisory Committee
SU
Third Party
Y

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 Human Med AG

K Number Device Name
K082025 BODY-JET