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FDA 510(k) Application Details - K042567
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K042567
Device Name
Surgeon'S Gloves
Applicant
PT. MEDISAFE TECHNOLOGIES
JL.BATANG KUIS GG.TAMBAK REJO
DESA BUNTU BEDIMBAR TJ. MORAWA
MEDAN, NORTH SUMATERA 20362 ID
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Contact
ANIL TANEJA
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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
09/21/2004
Decision Date
01/13/2005
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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