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510(k) K915741

DISPOSABLE MONOPLAR MEDDLE ELECTRODES by Dantec Medical, Inc. — Product Code GXE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 1992
Date Received
December 20, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Leukotome
Device Class
Class I
Regulation Number
882.4600
Review Panel
NE
Submission Type

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