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FDA 510(k) Application Details - K221759
Device Classification Name
Media, Corneal Storage
More FDA Info for this Device
510(K) Number
K221759
Device Name
Media, Corneal Storage
Applicant
Aurolab
No.1, Sivagangai Main Road
Veerapanjan, Madurai 625020 IN
Other 510(k) Applications for this Company
Contact
Krishna Kumar
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LYX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/17/2022
Decision Date
10/05/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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