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FDA 510(k) Application Details - K960719
Device Classification Name
Handpiece, Belt And/Or Gear Driven, Dental
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510(K) Number
K960719
Device Name
Handpiece, Belt And/Or Gear Driven, Dental
Applicant
DENTALEZ GROUP
1816 COLONIAL VILLAGE LN.
LANCASTER, PA 17601 US
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Contact
JEFF PEINHARDT
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Regulation Number
872.4200
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Classification Product Code
EFA
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More FDA Info for this Product Code
Date Received
02/21/1996
Decision Date
03/28/1996
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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