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FDA 510(k) Application Details - K101563
Device Classification Name
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
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510(K) Number
K101563
Device Name
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
Applicant
JEIL MEDICAL CORPORATION
1006 DIGITAL 2CHA VALLEY
BYUCKSAN, GASAN- DONG, GEUMCHE
SEOUL KR
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KIM SEONG NAM
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Regulation Number
000.0000
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Classification Product Code
KIJ
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Date Received
06/04/2010
Decision Date
12/17/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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