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FDA 510(k) Application Details - K971044
Device Classification Name
Latex Patient Examination Glove
More FDA Info for this Device
510(K) Number
K971044
Device Name
Latex Patient Examination Glove
Applicant
DASH MEDICAL GLOVES, INC.
10180 SOUTH 54TH ST.
FRANKLIN, WI 53132 US
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Contact
ROBERT J SULLIVAN JR.
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Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LYY
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More FDA Info for this Product Code
Date Received
03/21/1997
Decision Date
08/25/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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