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FDA 510(k) Application Details - K033243
Device Classification Name
Abutment, Implant, Dental, Endosseous
More FDA Info for this Device
510(K) Number
K033243
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
STRAUMANN USA
RESERVOIR PLACE,
1601 TRAPELO ROAD
WALTHAM, MA 02154 US
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Contact
LINDA JALBERT
Other 510(k) Applications for this Contact
Regulation Number
872.3630
More FDA Info for this Regulation Number
Classification Product Code
NHA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/07/2003
Decision Date
10/20/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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