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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, Retropubic Or Transobturator
510(k) Number K980482
Device Name TRIANGLE SLING
Applicant
Influence, Inc.
11812 Quince Mill Dr.
North Potomac,  MD  20878
Applicant Contact MARK D KRAMER
Correspondent
Influence, Inc.
11812 Quince Mill Dr.
North Potomac,  MD  20878
Correspondent Contact MARK D KRAMER
Regulation Number878.3300
Classification Product Code
OTN  
Date Received02/09/1998
Decision Date 03/27/1998
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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