FDA 510(k) Application Details - K022959

Device Classification Name Syringe, Cartridge

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510(K) Number K022959
Device Name Syringe, Cartridge
Applicant MDC RESEARCH LTD.
21911 ERIE LN.
LAKE FOREST, CA 92630 US
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Contact CAROL PATTERSON
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Regulation Number 872.6770

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Classification Product Code EJI
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Date Received 09/06/2002
Decision Date 02/05/2003
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



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