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FDA 510(k) Application Details - K972407
Device Classification Name
Locator, Root Apex
More FDA Info for this Device
510(K) Number
K972407
Device Name
Locator, Root Apex
Applicant
TOEI ELECTRIC CO., LTD.
1300 I STREET, N.W.
WASHINGTON, DC 20005 US
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Contact
ROBERT P REZNICK
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Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LQY
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More FDA Info for this Product Code
Date Received
06/26/1997
Decision Date
09/11/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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