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FDA 510(k) Application Details - K971196
Device Classification Name
Implant, Endosseous, Root-Form
More FDA Info for this Device
510(K) Number
K971196
Device Name
Implant, Endosseous, Root-Form
Applicant
INNOVA CORP.
C/O HOGAN & HARTSON
555 THIRTEENTH STREET, N.W.
WASHINGTON, DC 20004 US
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Contact
HOWARD M HOLSTEIN
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Regulation Number
872.3640
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Classification Product Code
DZE
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More FDA Info for this Product Code
Date Received
03/31/1997
Decision Date
05/08/1997
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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