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FDA 510(k) Application Details - K964230
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K964230
Device Name
Syringe, Piston
Applicant
CORE HEALTHCARE LTD.
46 LOCK HAVEN LN.
BATTLE CREEK, MI 49015 US
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Contact
KUMAR KULKARNI
Other 510(k) Applications for this Contact
Regulation Number
880.5860
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Classification Product Code
FMF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/23/1996
Decision Date
07/24/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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