FDA 510(k) Application Details - K955514

Device Classification Name Container, Sharps

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510(K) Number K955514
Device Name Container, Sharps
Applicant DURA-VAC PRODUCTS
4464 MCGRATH ST., #114
VENTURA, CA 93003 US
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Contact NEAL SHULTS
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Regulation Number 880.5570

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Classification Product Code MMK
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Date Received 12/04/1995
Decision Date 08/01/1996
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

FDA Source Information for K955514


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