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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 K973022
Device Name ISLAND BIOSURGICAL INC. BNS KIT #1 & #2
Applicant
Island Biosurgical, Inc.
18 Meadow Ln.
Mercer Island,  WA  98040 -5340
Applicant Contact HUNTER A MCKAY
Correspondent
Island Biosurgical, Inc.
18 Meadow Ln.
Mercer Island,  WA  98040 -5340
Correspondent Contact HUNTER A MCKAY
Regulation Number878.3300
Classification Product Code
OTN  
Date Received08/14/1997
Decision Date 10/20/1997
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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