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510(k) K020080

BONART ART-E1 ELECTROSURGERY UNIT by Diagnostic Data, Inc. — Product Code EKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 2002
Date Received
January 9, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, And Accessories, Dental
Device Class
Class II
Regulation Number
872.4920
Review Panel
DE
Submission Type

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