← FDA Medical Device Classifications

Bone Marrow Processing Device For Clinical Use

PZU · Not classified · Unknown

Classification

FDA Product Code
PZU
Device class
Not classified
Regulation
Review panel
HE
Medical specialty
Unknown
Submission type
3
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Definition

Preparation of concentrated bone marrow aspirate (cBMA) from a sample of bone marrow for clinical use

Market data

Cleared 510(k) submissions
0
Registered establishments
1

Source

Authoritative
FDA Device Classification database
Machine
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