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FDA 510(k) Application Details - K122998
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K122998
Device Name
Polymer Patient Examination Glove
Applicant
NORTHSTAR HEALTHCARE HOLDINGS
1202 SOUTH ROUTE 31
MCHENRY, IL 60050 US
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Contact
ANTHONY GIACCIO
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LZA
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More FDA Info for this Product Code
Date Received
09/27/2012
Decision Date
11/06/2012
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
Y
Expedited Review
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