FDA 510(k) Application Details - K073684

Device Classification Name Lubricant, Patient

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510(K) Number K073684
Device Name Lubricant, Patient
Applicant SHEFFIELD INDUSTRIES, DIV. OF FARIA LTD.
170 BROAD ST.
NEW LONDON, CT 06320 US
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Contact KATHLEEN HACKU
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Regulation Number 880.6375

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Classification Product Code KMJ
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Date Received 12/28/2007
Decision Date 05/22/2008
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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