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FDA 510(k) Application Details - K212544
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K212544
Device Name
Syringe, Piston
Applicant
OcuJect, LLC
1441 Avocado Ave, Suite 204
Newport Beach, CA 92660 US
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Contact
Rebecca K Pine
Other 510(k) Applications for this Contact
Regulation Number
880.5860
More FDA Info for this Regulation Number
Classification Product Code
FMF
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More FDA Info for this Product Code
Date Received
08/12/2021
Decision Date
10/13/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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