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

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

K Number: K170449 · Decision Mar 31, 2017
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
39
Applicant Total
1
Review Days
44

Basic Information

Device Name
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
K Number
K170449
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
Millennium Medical Technologies, Inc.
Date Received
February 15, 2017
Decision Date
March 31, 2017
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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