FDA 510(k) Application Details - K002709

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

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510(K) Number K002709
Device Name Handpiece, Belt And/Or Gear Driven, Dental
Applicant AMC GENERAL, INC.
800 KING GEORGE BLVD.
SAVANNAH, GA 31419 US
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Contact RAY T BURKE
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Regulation Number 872.4200

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Classification Product Code EFA
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Date Received 08/30/2000
Decision Date 11/17/2000
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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