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FDA 510(k) Application Details - K050899
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K050899
Device Name
Surgeon'S Gloves
Applicant
REGENT MEDICAL AMERICAS, LLC
3585 ENGINEERING DR, STE 250
NORCROSS, GA 30092 US
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Contact
KATHLEEN HARRIS
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
04/11/2005
Decision Date
08/12/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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