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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urological
510(k) Number K001583
Device Name ISLAND BIOSURGICAL BNS KIT #3
Applicant
Island Biosurgical, LLC
18 Meadow Ln.
Mercer Island,  WA  98040 -5340
Applicant Contact HUNTER A MCKAY
Correspondent
Island Biosurgical, LLC
18 Meadow Ln.
Mercer Island,  WA  98040 -5340
Correspondent Contact HUNTER A MCKAY
Regulation Number876.5130
Classification Product Code
KOD  
Subsequent Product Code
FEW  
Date Received05/22/2000
Decision Date 07/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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