FDA 510(k) Application Details - K960541

Device Classification Name Handpiece, Air-Powered, Dental

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510(K) Number K960541
Device Name Handpiece, Air-Powered, Dental
Applicant MTI PRECISION PRODUCTS
1129 BLOOMFIELD AVE.
WEST CALDWELL, NJ 07006 US
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Contact ANNE MARIE CESARIO
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Regulation Number 872.4200

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Classification Product Code EFB
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Date Received 02/07/1996
Decision Date 03/28/1996
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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