FDA 510(k) Application Details - K121898

Device Classification Name Fiber, Medical, Absorbent

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510(K) Number K121898
Device Name Fiber, Medical, Absorbent
Applicant QUICK-MED TECHNOLOGIES, INC.
49 PLAIN STREET
NORTH ATTLEBORO, MA 02760 US
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Contact MARY MCNAMARA-CULLINANE
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Regulation Number 880.5300

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Classification Product Code FRL
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Date Received 06/29/2012
Decision Date 05/24/2013
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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