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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Catheter, G-U
510(k) Number K112209
Device Name PREFILLED CATHETER INFLATION SYRINGE
Applicant
AVAIL MEDICAL PRODUCTS, INC.
5950 NANCY RIDGE ROAD
SUITE 500
SAN DIEGO,  CA  92121
Applicant Contact STEVEN A HOWELL
Correspondent
AVAIL MEDICAL PRODUCTS, INC.
5950 NANCY RIDGE ROAD
SUITE 500
SAN DIEGO,  CA  92121
Correspondent Contact STEVEN A HOWELL
Regulation Number876.5130
Classification Product Code
KNY  
Date Received08/01/2011
Decision Date 09/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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