FDA 510(k) Application Details - K022032

Device Classification Name Clasp, Preformed

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510(K) Number K022032
Device Name Clasp, Preformed
Applicant INOVATIV, LLC
1155 TWIN HILLS DR.
JEFFERSON, OR 97352 US
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Contact ROBERT BOWERS
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Regulation Number 872.3285

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Classification Product Code EHP
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Date Received 06/21/2002
Decision Date 08/29/2002
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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