FDA 510(k) Application Details - K022415

Device Classification Name Needle, Hypodermic, Single Lumen

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510(K) Number K022415
Device Name Needle, Hypodermic, Single Lumen
Applicant WAISMED LTD.
117 AHUZAH ST
RA'ANANNA IL
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Contact DORIT WINITZ
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Regulation Number 880.5570

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Classification Product Code FMI
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Date Received 07/24/2002
Decision Date 10/11/2002
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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