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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 K090121
Device Name PRE-FILLED CATHETER INFLATION SYRINGE
Applicant
Avail Medical Products, Inc.
1900 E. Carnegie Ave.
Santa Ana,  CA  92705
Applicant Contact PATRICIA A GOEREE
Correspondent
Avail Medical Products, Inc.
1900 E. Carnegie Ave.
Santa Ana,  CA  92705
Correspondent Contact PATRICIA A GOEREE
Regulation Number876.5130
Classification Product Code
KNY  
Date Received01/21/2009
Decision Date 04/15/2009
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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