FDA 510(k) Application Details - K970953

Device Classification Name Handpiece, Rotary Bone Cutting

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510(K) Number K970953
Device Name Handpiece, Rotary Bone Cutting
Applicant NSK NAKANISHI, INC.
340 KAMIHINATA,KANUMA-SHI
TOCHIGI-KEN 322 JP
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Contact HIROJI SEKIGUCHI
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Regulation Number 872.4120

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Classification Product Code KMW
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Date Received 03/17/1997
Decision Date 04/15/1997
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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