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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
510(k) Number K023898
Device Name GYNE IDEAS MINITAPE RP DEVICE
Applicant
Gyne Ideas , Ltd.
150 Aran Hill Rd.
Farfield,  CT  06824
Applicant Contact LOUIS MAZZARESE
Correspondent
Gyne Ideas , Ltd.
150 Aran Hill Rd.
Farfield,  CT  06824
Correspondent Contact LOUIS MAZZARESE
Regulation Number878.3300
Classification Product Code
PAH  
Date Received11/22/2002
Decision Date 06/18/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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