FDA 510(k) Application Details - K992158

Device Classification Name Plate, Bone

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510(K) Number K992158
Device Name Plate, Bone
Applicant BIOMET, INC.
AIRPORT INDUSTRIAL PARK,
P.O.BOX 587
WARSAW, IN 46581-0587 US
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Contact MICHELLE L MCKINLEY
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Regulation Number 872.4760

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Classification Product Code JEY
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Date Received 06/25/1999
Decision Date 08/20/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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