FDA 510(k) Application Details - K111734

Device Classification Name Syringe, Antistick

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510(K) Number K111734
Device Name Syringe, Antistick
Applicant MEDICALCHAIN INTL. CORP.
1808 SEABREEZE COUNT,
THOUSAND OAKS, CA 91320 US
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Contact ROBIN HWANG
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Regulation Number 880.5860

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Classification Product Code MEG
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Date Received 06/21/2011
Decision Date 09/06/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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