FDA 510(k) Application Details - K052397

Device Classification Name Syringe, Antistick

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510(K) Number K052397
Device Name Syringe, Antistick
Applicant LIFE-SHIELD PRODUCTS, INC
3F, NO 10, WUCHIUAN 7TH RD
WUGU INDUSTRIAL PARK
TAIPEI 248 TW
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Contact Ke-Min Jen
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Regulation Number 880.5860

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Classification Product Code MEG
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Date Received 08/31/2005
Decision Date 12/22/2005
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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