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FDA 510(k) Application Details - K180646
Device Classification Name
Patient Examination Glove, Specialty
More FDA Info for this Device
510(K) Number
K180646
Device Name
Patient Examination Glove, Specialty
Applicant
Halyard Health
5405 Windward Parkway
Alpharetta, GA 30004 US
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Contact
Christine L. Macauley
Other 510(k) Applications for this Contact
Regulation Number
880.6250
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Classification Product Code
LZC
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More FDA Info for this Product Code
Date Received
03/12/2018
Decision Date
06/27/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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