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FDA 510(k) Application Details - K001729
Device Classification Name
Unit, X-Ray, Extraoral With Timer
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510(K) Number
K001729
Device Name
Unit, X-Ray, Extraoral With Timer
Applicant
INSTRUMENTARIUM CORP.
300 WEST EDGERTON AVE.
MILWAUKEE, WI 53207 US
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Contact
DOUG WOODS
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Regulation Number
872.1800
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Classification Product Code
EHD
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More FDA Info for this Product Code
Date Received
06/07/2000
Decision Date
07/13/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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