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KCX · Class I — Low Risk (general controls) · General, Plastic Surgery · 21 CFR 878.5360

Classification

FDA Product Code
KCX
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 878.5360
Review panel
SU
Medical specialty
General, Plastic Surgery
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Market data

Cleared 510(k) submissions
25
Registered establishments
30

Source

Authoritative
FDA Device Classification database
Machine
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