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510(k) K864146

DEKNATEL GWATHMEY VASCULAR STAPLING KIT (TENATIVE) by Cardio Thoracic Systems — Product Code GDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1986
Date Received
October 22, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Implantable
Device Class
Class II
Regulation Number
878.4750
Review Panel
SU
Submission Type

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