FDA 510(k) Application Details - K011222

Device Classification Name Unit, Operative Dental

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510(K) Number K011222
Device Name Unit, Operative Dental
Applicant BELL DENTAL PRODUCTS, LLC.
3003 ARAPAHOE ST., #101-B
DENVER, CO 80205 US
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Contact DAN BELL
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Regulation Number 872.6640

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Classification Product Code EIA
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Date Received 04/20/2001
Decision Date 06/25/2001
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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