FDA 510(k) Application Details - K981526

Device Classification Name Plate, Bone

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510(K) Number K981526
Device Name Plate, Bone
Applicant ACE SURGICAL SUPPLY CO., INC.
1034 PEARL ST.
BROCKTON, MA 02301 US
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Contact EDWARD J CARCHIDI
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Regulation Number 872.4760

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Classification Product Code JEY
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Date Received 04/28/1998
Decision Date 11/06/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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