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FDA 510(k) Application Details - K974603
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K974603
Device Name
Plate, Fixation, Bone
Applicant
ATLAS TECHNOLOGY
344 ANNABELLE POINT RD.
CENTERVILLE,, MA 02632-2402 US
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Contact
HILLARD W WELCH
Other 510(k) Applications for this Contact
Regulation Number
888.3030
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Classification Product Code
HRS
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More FDA Info for this Product Code
Date Received
12/10/1997
Decision Date
03/10/1998
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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