510(k) K974600

UROMED PATCH by Uromed Corp. — Product Code MNG

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 31, 1998
Date Received: December 9, 1997
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: External Urethral Occluder, Urinary Incontinence-Control, Female
Device Class: Class I
Regulation Number: 876.5160
Review Panel: GU
Submission Type

Intended to prevent or decrease episodes of urine leakage in women with stress incontinence. Occluder is applied to urinary meatus through suction or tape, which creates a barrier for urine leakage. Occluding device such as a cap, suction cup, or foam pad. May include adhesive gel or ointment.

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510(k) K974600

Clearance Details

Device Classification

Other clearances by Uromed Corp.

Other clearances for product code MNG