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FDA 510(k) Application Details - K983535
Device Classification Name
Plate, Bone
More FDA Info for this Device
510(K) Number
K983535
Device Name
Plate, Bone
Applicant
HANS HERMANN GMBH
UNTERER WINKEL 3
WURMLINGEN D-78567 DE
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Contact
DAGMAR S MASER
Other 510(k) Applications for this Contact
Regulation Number
872.4760
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Classification Product Code
JEY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/09/1998
Decision Date
12/29/1998
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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