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FDA 510(k) Application Details - K021993
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K021993
Device Name
Syringe, Piston
Applicant
SHANGDONG ZIBO SHANCHUAN MEDICAL INSTRUMENTS CO.
12951 BRIAR FOREST DRIVE # 303
HOUSTON, TX 77077 US
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Contact
HAIRONG CHE
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
06/18/2002
Decision Date
06/03/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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