← FDA Medical Device Classifications

Agent, Absorbable Hemostatic, Collagen Based

LMF · Class III — High Risk (PMA approval required, life-sustaining) · General, Plastic Surgery · 21 CFR 878.4490

Classification

FDA Product Code
LMF
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
21 CFR 878.4490
Review panel
SU
Medical specialty
General, Plastic Surgery
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N

Market data

Cleared 510(k) submissions
0
Registered establishments
34

Source

Authoritative
FDA Device Classification database
Machine
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