FDA 510(k) Application Details - K021524

Device Classification Name Dam, Rubber

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510(K) Number K021524
Device Name Dam, Rubber
Applicant PRIME DENTAL MANUFACTURING, INC.
3735 WEST BELMONT AVE.
CHICAGO, IL 60618 US
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Contact ROLANDO MARASIGAN
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Regulation Number 872.6300

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Classification Product Code EIE
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Date Received 05/10/2002
Decision Date 07/19/2002
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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