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510(k) K191739

Sterile LeadConfirm by Alpha Omega Engineering , Ltd. — Product Code GZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 2020
Date Received
June 28, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Depth
Device Class
Class II
Regulation Number
882.1330
Review Panel
NE
Submission Type

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