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FDA 510(k) Application Details - K991566
Device Classification Name
Staple, Fixation, Bone
More FDA Info for this Device
510(K) Number
K991566
Device Name
Staple, Fixation, Bone
Applicant
NEWDEAL S.A.
9109 COPENHAVER DR.
POTOMAC, MD 20854 US
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Contact
NORMAN F ESTRIN
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Regulation Number
888.3030
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Classification Product Code
JDR
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More FDA Info for this Product Code
Date Received
05/05/1999
Decision Date
08/03/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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