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510(k) K023898

GYNE IDEAS MINITAPE RP DEVICE by Gyne Ideas , Ltd. — Product Code PAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2003
Date Received
November 22, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
Device Class
Class II
Regulation Number
878.3300
Review Panel
GU
Submission Type

Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility.

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