FDA 510(k) Application Details - K034017

Device Classification Name Ring, Teething, Non-Fluid Filled

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510(K) Number K034017
Device Name Ring, Teething, Non-Fluid Filled
Applicant VIBE 2000
21911 ERIE LANE
LAKE FOREST, CA 93030 US
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Contact CAROL PATTERSON
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Regulation Number 872.5550

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Classification Product Code MEF
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Date Received 12/24/2003
Decision Date 10/18/2004
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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