FDA 510(k) Application Details - K021522

Device Classification Name Screw, Fixation, Intraosseous

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510(K) Number K021522
Device Name Screw, Fixation, Intraosseous
Applicant WALTER LORENZ SURGICAL, INC.
1520 TRADEPORT DR.
JACKSONVILLE, FL 32218 US
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Contact SHERYL MALMBERG
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Regulation Number 872.4880

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Classification Product Code DZL
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Date Received 05/10/2002
Decision Date 05/21/2002
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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