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FDA 510(k) Application Details - K971002
Device Classification Name
Cushion, Denture, Over The Counter
More FDA Info for this Device
510(K) Number
K971002
Device Name
Cushion, Denture, Over The Counter
Applicant
LLOYD V. ZIEMENDORF
6762 WARD RD.
NIAGARA FALLS, NY 14304-4556 US
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Contact
LLOYD V ZIEMENDORF
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Regulation Number
872.3540
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Classification Product Code
EHS
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More FDA Info for this Product Code
Date Received
03/19/1997
Decision Date
07/15/1997
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
FDA Source Information for K971002
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