FDA 510(k) Application Details - K014263

Device Classification Name Plate, Bone

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510(K) Number K014263
Device Name Plate, Bone
Applicant STRYKER INSTRUMENTS
4100 EAST MILHAM AVE.
KALAMAZOO, MI 49001-6197 US
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Contact ROBIN L ROWE
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Regulation Number 872.4760

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Classification Product Code JEY
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Date Received 12/27/2001
Decision Date 03/08/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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