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510(k) K854569

HEMOR-ICE by Technology 2000 — Product Code LKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1986
Date Received
November 14, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Thermal, Hemorrhoids
Device Class
Class U
Regulation Number
Review Panel
GU
Submission Type

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