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FDA 510(k) Application Details - K222689
Device Classification Name
More FDA Info for this Device
510(K) Number
K222689
Device Name
Mallya Injection Pen Adapter (Mallya« for Solostar«)
Applicant
Biocorp Production
Zi Lavaur -La BΘchade
Issoire 63500 FR
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Contact
Alexia Garin
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QOG
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More FDA Info for this Product Code
Date Received
09/06/2022
Decision Date
12/05/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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