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FDA 510(k) Application Details - K030228
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K030228
Device Name
Surgeon'S Gloves
Applicant
PT. MEDISAFE TECHNOLOGIES
JL. KAPT. PATTIMURA NO. 23
MEDAN, NORTH SUMATRA 20153 ID
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Contact
ANIL TANEJA
Other 510(k) Applications for this Contact
Regulation Number
878.4460
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Classification Product Code
KGO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/22/2003
Decision Date
03/14/2003
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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