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FDA 510(k) Application Details - K954471
Device Classification Name
Unit, Operative Dental
More FDA Info for this Device
510(K) Number
K954471
Device Name
Unit, Operative Dental
Applicant
POWERS DENTAL & MEDICAL TECHNOLOGY, INC.
1855 WALDORF N.W.
GRAND RAPIDS, MI 49544 US
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Contact
SUSAN NEUMAN
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Regulation Number
872.6640
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Classification Product Code
EIA
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More FDA Info for this Product Code
Date Received
09/26/1995
Decision Date
04/15/1996
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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