FDA 510(k) Application Details - K981202

Device Classification Name Ring, Teething, Fluid-Filled

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510(K) Number K981202
Device Name Ring, Teething, Fluid-Filled
Applicant CORIUM CORP.
P.O. BOX 4084
MONROE, LA 71211 US
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Contact JOSEPH HAKIM
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Regulation Number 872.5550

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Classification Product Code KKO
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Date Received 04/02/1998
Decision Date 06/16/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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