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FDA 510(k) Application Details - K202544
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K202544
Device Name
Syringe, Piston
Applicant
Instylla, Inc.
201 Burlington Rd, North Building
Bedford, MA 01730 US
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Contact
Jennifer Greer
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Regulation Number
880.5860
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Classification Product Code
FMF
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More FDA Info for this Product Code
Date Received
09/02/2020
Decision Date
01/07/2021
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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