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FDA 510(k) Application Details - K032444
Device Classification Name
Patient Examination Glove, Specialty
More FDA Info for this Device
510(K) Number
K032444
Device Name
Patient Examination Glove, Specialty
Applicant
Cardinal Health
1500 WAUKEGAN RD. BLDG. WM
MCGAW PARK, IL 60085 US
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Contact
ERICA SETHI
Other 510(k) Applications for this Contact
Regulation Number
880.6250
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Classification Product Code
LZC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/08/2003
Decision Date
11/13/2003
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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