FDA 510(k) Application Details - K072082

Device Classification Name Ring, Teething, Fluid-Filled

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510(K) Number K072082
Device Name Ring, Teething, Fluid-Filled
Applicant BIOMEDEVICE LTD.
24931 NELLIE GAIL ROAD
LAGUNA HILLS, CA 92653 US
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Contact BRICE L YODER
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Regulation Number 872.5550

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Classification Product Code KKO
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Date Received 07/30/2007
Decision Date 11/05/2007
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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