FDA 510(k) Application Details - K023672

Device Classification Name Unit, Electrosurgical, And Accessories, Dental

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510(K) Number K023672
Device Name Unit, Electrosurgical, And Accessories, Dental
Applicant XO CARE A/S
1100 S. COAST HIGHWAY STE. 204
LAGUNGA BEACH, CA 92651 US
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Contact JAMES DIEROFF
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Regulation Number 872.4920

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Classification Product Code EKZ
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Date Received 11/01/2002
Decision Date 04/29/2003
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

FDA Source Information for K023672


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