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FDA 510(k) Application Details - K042534
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K042534
Device Name
Surgeon'S Gloves
Applicant
MARINA MEDICAL INSTRUMENTS, INC.
1308 MORNINGSIDE PARK DR.
ALPHARETTA, GA 30022 US
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Contact
JAY MANSOUR
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
09/17/2004
Decision Date
05/10/2005
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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