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510(k) K001521

SOFTSENS by Integrated Biosensing Technologies — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 2000
Date Received
May 16, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Cutaneous
Device Class
Class II
Regulation Number
882.1320
Review Panel
NE
Submission Type

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