FDA 510(k) Application Details - K050134

Device Classification Name Syringe, Antistick

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510(K) Number K050134
Device Name Syringe, Antistick
Applicant FORMOSA MEDICAL DEVICES, INC.
16F,NO.182,SECT.2
TUNHUA S. ROAD
TAIPEI 106 TW
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Contact C. Y. LIN
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Regulation Number 880.5860

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Classification Product Code MEG
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Date Received 01/21/2005
Decision Date 04/05/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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