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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 K952414
Device Name PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETER
Applicant
Acacia Laboratories, Inc.
1719 S. Grand Ave.
Santa Ana,  CA  92705
Applicant Contact BEN WALTHALL
Correspondent
Acacia Laboratories, Inc.
1719 S. Grand Ave.
Santa Ana,  CA  92705
Correspondent Contact BEN WALTHALL
Regulation Number876.5130
Classification Product Code
KNY  
Date Received05/23/1995
Decision Date 06/23/1995
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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