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510(k) K192033

Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip by Bennett Jacoby, Dds, Ms, Inc. — Product Code DZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2020
Date Received
July 30, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drill, Bone, Powered
Device Class
Class II
Regulation Number
872.4120
Review Panel
DE
Submission Type

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