FDA 510(k) Application Details - K973062

Device Classification Name Handpiece, Belt And/Or Gear Driven, Dental

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510(K) Number K973062
Device Name Handpiece, Belt And/Or Gear Driven, Dental
Applicant MEDIDENTA INTL., INC.
39-23 62ND ST.
WOODSIDE, NY 11377 US
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Contact ROBERT T POSTAL
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Regulation Number 872.4200

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Classification Product Code EFA
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Date Received 08/18/1997
Decision Date 10/09/1997
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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