FDA 510(k) Application Details - K955654

Device Classification Name Handpiece, Air-Powered, Dental

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510(K) Number K955654
Device Name Handpiece, Air-Powered, Dental
Applicant SPINTECH, INC.
218 DEW DROP RD.
YORK, PA 17402 US
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Contact RONALD P SPINELLO
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Regulation Number 872.4200

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Classification Product Code EFB
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Date Received 12/12/1995
Decision Date 02/08/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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