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FDA 510(k) Application Details - K012819
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K012819
Device Name
Surgeon'S Gloves
Applicant
SEMPERIT TECHNISCHE PRODUKTE GESELLSHAFT
1308 MORNINGSTAR PARK DR.
APHARETTA, GA 30022 US
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Contact
JAY MANSOUR
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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
08/23/2001
Decision Date
11/16/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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