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FDA 510(k) Application Details - K073684
Device Classification Name
Lubricant, Patient
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
880.6375
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Classification Product Code
KMJ
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More FDA Info for this Product Code
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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