FDA 510(k) Application Details - K023486

Device Classification Name Plate, Bone

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510(K) Number K023486
Device Name Plate, Bone
Applicant BIOMEDICAL ENTERPRISES, INC
14785 OMICRON DR STE 205
SAN ANTONIO, TX 78245 US
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Contact W. CASEY FOX
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Regulation Number 872.4760

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Classification Product Code JEY
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Date Received 10/17/2002
Decision Date 10/31/2002
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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