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FDA 510(k) Application Details - K111413
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K111413
Device Name
Surgeon'S Gloves
Applicant
MOLNLYCKE HEALTHCARE, US LLC
5550 PEACHTREE PARKWAY
SUITE 500
NORCROSS, GA 30092 US
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Contact
ANGELA L BUNN
Other 510(k) Applications for this Contact
Regulation Number
878.4460
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Classification Product Code
KGO
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More FDA Info for this Product Code
Date Received
05/20/2011
Decision Date
01/30/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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