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FDA 510(k) Application Details - K991037
Device Classification Name
Nail, Fixation, Bone
More FDA Info for this Device
510(K) Number
K991037
Device Name
Nail, Fixation, Bone
Applicant
MODULAR CUTTING SYSTEMS, INC.
650 CLINTON AVE.
BRIDGEPORT, CT 06605 US
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Contact
ALLEN P SCHLEIN
Other 510(k) Applications for this Contact
Regulation Number
888.3030
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Classification Product Code
JDS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/29/1999
Decision Date
06/23/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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