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FDA 510(k) Application Details - K071565
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K071565
Device Name
Surgeon'S Gloves
Applicant
MOLNLYCKE HEALTH CARE US, LLC
5550 PEACHTREE PARKWAY
SUITE 500
NORCROSS, GA 30092 US
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Contact
STEVEN DOWDLEY
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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
06/07/2007
Decision Date
09/10/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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