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510(k) K955810

U-TEX by Laborie Medical Technologies, Ltd. — Product Code FHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1996
Date Received
December 26, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Penile
Device Class
Class I
Regulation Number
876.5160
Review Panel
GU
Submission Type

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