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510(k) K990983

MODIFICATION TO IMTEC SENDAX MDI by Imtec Corp. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 1999
Date Received
March 24, 1999
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Root-Form
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type

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  • K030243 — ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,4314 (April 23, 2003)
  • K024044 — SABER TECH IMPLANTS SYSTEM (February 21, 2003)

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