FDA 510(k) Application Details - K021993

Device Classification Name Syringe, Piston

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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
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Regulation Number 880.5860

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Classification Product Code FMF
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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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