FDA 510(k) Application Details - K071809

Device Classification Name Plate, Fixation, Bone

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510(K) Number K071809
Device Name Plate, Fixation, Bone
Applicant SONOMA ORTHOPEDIC PRODUCTS, INC.
650 LARKFIELD CENTER
SANTA ROSA, CA 95403 US
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Contact CHARLES L NELSON
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Regulation Number 888.3030

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Classification Product Code HRS
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Date Received 07/02/2007
Decision Date 02/21/2008
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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