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FDA 510(k) Application Details - K173385
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K173385
Device Name
Syringe, Piston
Applicant
Micromedics, Inc. (d/b/a Nordson MEDICAL)
1270 Eagan Industrial Road, Suite 120
St. Paul, MN 55121 US
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Contact
Kristi Brezinka
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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
10/30/2017
Decision Date
11/30/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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