Atlas FDA

MicroMatrix

FDA 510(k) clearance K153754 · decided 2016-03-14

Clearance details

K-number
K153754
Device name
MicroMatrix
Applicant
Acell, Inc.
Decision
Substantially Equivalent
Date received
2015-12-29
Decision date
2016-03-14
Days to decision
76 days
Clearance type
Special
Product code
KGN
Device class
U
Medical specialty
Unknown
Advisory committee
Unknown
Location
Columbia, MD, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.